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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The American Medical Association is calling for a Senate probe into RFK Jr. after he removed all 17 members of the CDC's vaccine advisory board. They are also urging an immediate reversal of the HHS Secretary's decision. In other news, FDA leaders promise support for gene therapy as it faces challenges, Novo Nordisk invests over $800 million in discovering oral obesity drugs, and a new company, InVitro Cell Research, focuses on interventions to slow aging and prevent age-related diseases. FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article outlining the FDA's priorities, including accelerating cures and deploying artificial intelligence quickly. Other news includes Lilly's muscle-preserving treatment pact, Vertex laying off staff after axing a diabetes asset, and Genentech reshuffling in South San Francisco. Recursion cuts workforce by 20%.FDA leaders have pledged support to gene therapy makers as the industry faces challenges in commercialization. Despite huge valuations, gene therapies are struggling to reach the market. Poor communication about the value of groundbreaking treatments is hindering their prospects. Right of first negotiation deals do not always lead to mergers and acquisitions, as found by Jefferies in their analysis of licensing deals. Trilink's new comprehensive IVT kit simplifies the production of mRNAs. In other news, Lilly strikes a $650 million deal for a muscle-preserving treatment, Odyssey ends its quest for Nasdaq, BMS expands its radiopharma presence, and SpliceBio secures $135 million in funding for protein splicing medicines. Novo ups its obesity efforts with an $800 million pact, while Cullinan makes a $700 million deal for autoimmune T cell engager in China.Thank you for listening to Pharma and Biotech Daily.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Robert F. Kennedy Jr.'s removal of all members of the CDC's Advisory Committee on Immunization Practices has raised concerns about the upcoming meeting later this month. Analysts fear that the committee may become more sympathetic to anti-vaccine viewpoints. In other news, Merck has received FDA approval for an RSV antibody, Gilead has paused five HIV trials but Lenacapavir remains safe, and the FDA has reinstated a previously disbanded generic drug policy panel. Gilead has expressed faith in its HIV combo therapy and pledged to work with regulators to resolve the hold on its trials. In vitro cell research is focused on discovering interventions to slow aging and prevent age-related diseases.Kennedy's vaccine campaign is seen as breeding more distrust, while Metsera's weight loss injection has shown positive results. Merck is moving forward with an oral PCSK9 inhibitor. Thank you for tuning in to Pharma and Biotech daily for the latest updates in the pharmaceutical and biotechnology industries.
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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Metsera's new long-acting amylin injection, met-233i, has shown promising weight loss results over eight months, leading to a rise in shares. Meanwhile, CDC vaccine advisors are either being pushed out or leaving their positions. Other top stories include Sirna's expansion beyond the liver, Keros returning $375 million to investors, and ACIP members receiving termination notices. In vitro cell research is focused on slowing aging and preventing age-related diseases. Updates on Merck's oral PCSK9 inhibitor, Sanofi and Regeneron's Dupixent effectiveness, and Avidity's muscular dystrophy drug are also highlighted.The expansion of RNA therapeutics is discussed, with multiple companies aiming to target small interfering RNA to various organs by 2030. Uniqure's regulatory progress in developing a gene therapy for Huntington's disease has sparked optimism, although past disappointments for patients are noted. Perspective Therapeutics presents new data on neuroendocrine tumor treatment at ASCO25. Concerns about RFK Jr.'s vaccine campaign and its potential to increase distrust in vaccines are raised in the editorial. Cancer news, cell and gene therapy updates, upcoming events, job listings, and a call for reader suggestions on coverage topics are also covered.
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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.##News 1: FDA approves new drug for treatment of rare genetic diseaseIn a significant development for the rare disease community, the FDA has approved a new drug for the treatment of a rare genetic disease. The drug, which is the first of its kind, has shown promising results in clinical trials and is expected to provide much-needed relief for patients suffering from this condition.##News 2: Biotech company announces breakthrough in cancer researchA leading biotech company has announced a major breakthrough in cancer research. The company's new treatment has shown significant efficacy in treating a variety of cancers, offering hope to patients who previously had limited treatment options. This development marks a significant step forward in the fight against cancer.##News 3: Pharma company reports positive results in COVID-19 vaccine trialsA pharmaceutical company has reported positive results in clinical trials for its COVID-19 vaccine candidate. The vaccine has shown high efficacy rates in preventing infection and reducing the severity of symptoms in vaccinated individuals. This news comes as a welcome development in the ongoing battle against the global pandemic.##News 4: Biotech startup secures funding for innovative gene therapyA promising biotech startup has secured funding for its innovative gene therapy approach. The therapy, which targets a range of genetic disorders, has shown promising results in preclinical studies and is now moving towards clinical trials. This funding will help accelerate the development of the therapy and bring it one step closer to market availability.##News 5: Pharma giant announces collaboration with leading research institutionA major pharmaceutical company has announced a collaboration with a leading research institution to advance drug discovery efforts. The partnership aims to leverage the expertise of both organizations to accelerate the development of new treatments for a variety of diseases. This collaboration represents a significant step forward in the quest for innovative therapies.##News 6: Biotech conference showcases latest advancements in gene editing technologyA recent biotech conference showcased the latest advancements in gene editing technology. Researchers presented cutting-edge techniques that have the potential to revolutionize the field of genetic engineering. These advancements hold promise for developing new treatments for a wide range of diseases and disorders.##That's all for today's episode of Pharma and Biotech Daily. Stay tuned for more updates on the latest developments in the world of pharmaceuticals and biotechnology. Thank you for listening!
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Fired employees from the Department of Health and Human Services are suing Robert F. Kennedy Jr. and Elon Musk, claiming their terminations were based on inaccurate and error-ridden information. The lawsuit alleges that HHS leadership knew the records used to guide layoff decisions were flawed. UniQure's regulatory progress has sparked optimism for Huntington's disease patients, with analysts reacting positively to the company's accelerated approval pathway for a gene therapy submission in 2026. Cullinan has made a back-heavy deal in China worth over $700 million for autoimmune T cell engager technology, while Sarepta has won FDA's platform technology designation for gene therapy development. Rapt is shrinking after discontinuing a drug, agileAD is gearing up to challenge J&J in the multiple myeloma Car-T market, and Lilly has signed a deal for long-acting obesity drugs.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world.Jefferies predicts an increase in small tuck-in deals in the biotech industry as companies face challenges accessing capital. Companies and industry groups are offering solutions to mitigate the impact of Trump tariffs on rare disease, cell, and gene therapy. Pitchbook suggests a shift towards more sustainable investing in biotech VC firms. Gilead is gearing up to challenge J&J in the $20 billion multiple myeloma CAR-T market. PTP's generative AI is revolutionizing data summaries for biotech QC workflows. Sanofi recently acquired Blueprint for $9.5 billion, while BMS has committed up to $11 billion with Biontech. Lilly has signed a deal worth up to $870 million, and Regeneron is investing nearly $2 billion in a Chinese obesity drug. Merck's CEO is emphasizing diversity in operations following the defeat of an anti-DEI measure. Immuno-oncology drugs Keytruda and Opdivo may face scrutiny in the near future.In other news, Vigil Neuroscience's Trem2 antibody for a rare brain disease failed in a Phase II trial shortly after Sanofi's acquisition of the company. Analysts believe the results were not surprising and should not impact the deal. Lilly has signed a deal worth up to $870 million to develop a long-acting GLP-1 obesity drug, while the FDA is committed to making rare disease drugs available at the first sign of promise. Pharma tuck-in deals are increasing after a slow first quarter for small biotechs. BioAgc Biologics will be attending Bio International in Boston to discuss their global drug production capabilities.Stay tuned for more updates on investing in research, welcoming global talent, the biotech VC cycle, Gilead's challenge to J&J in the multiple myeloma CAR-T market, and much more. Upcoming events and job listings in the pharmaceutical industry are also featured in our newsletter.Thank you for tuning in to Pharma and Biotech daily.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Roche and Jazz Pharmaceuticals presented data at ASCO showing that their drug combination improved survival in a phase III lung cancer trial, with analysts noting a strong treatment effect. Jazz has filed for FDA approval for the combination, which could provide an alternative to monotherapy treatments from Roche and AstraZeneca. Trump's tariffs could potentially endanger the rare disease space, according to industry experts. Other news includes Kymera's success with a protein degrader candidate, Amgen's IMDelltra boosting survival in small cell lung cancer, and concerns about the impact of FDA guidelines on nitrosamine testing. BioAgilytix will be at BIO International to discuss their drug production capabilities. Other news includes Kura's new data in acute myeloid leukemia, Keros' layoffs, Regeneron's investment in a Chinese obesity drug, and Sanofi's acquisition of Blueprint to expand their rare disease portfolio. Upcoming events include webinars on AI in life science R&D and the crisis facing the pharma industry. Job opportunities in clinical data management, regulatory affairs, and scientific roles are also highlighted.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Regeneron's shares have dropped due to the failure of their dupixent follow-up drug, while Sanofi has acquired Blueprint for $9.5 billion to expand their rare disease portfolio. Bristol Myers Squibb is collaborating with Biontech on a bispecific antibody for solid tumors, and Amgen's imdelltra has shown a 40% increase in survival for small cell lung cancer at ASCO. Moderna has received FDA approval for their next-gen COVID-19 vaccine, and AstraZeneca is partnering with AI companies to stop cancer at all stages. Keros has cut 45% of its workforce along with a pulmonary hypertension drug, and Jazz has presented new cancer data at ASCO. FDA actions are pending for companies like Merck, Gilead, and Regeneron/Sanofi.The implications of the overturning of the FDA's lab-developed tests rule in a post-Chevron legal landscape are discussed, where power has shifted from federal agencies to the courts. Upcoming FDA decisions, including Gilead's HIV prophylaxis lenacapavir, are highlighted, along with new FDA guidelines on nitrosamine testing for the pharmaceutical industry. Jazz Pharmaceuticals is in the "goldilocks zone" with new cancer data at ASCO25, showcasing results from acquisitions made over the past five years. Zeiss introduces an AI-powered spatial biology solution for research labs. Other news includes updates from ASCO25, cell and gene therapy developments, and upcoming events in the biopharma industry.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The Summit's bispecific drug missed the survival endpoint in a global Phase III trial, but analysts remain optimistic about its potential to appeal to both Eastern and Western patient populations. Sanofi and Regeneron saw their shares tumble after a follow-up drug failed a Phase III COPD test. RFK Jr.'s report on health was found to have fake citations, casting doubt on its credibility. Astellas made a $1.5 billion bet on a Chinese collaboration for a cancer drug. In other news, Merck CEO emphasized the importance of diversity, while other companies faced setbacks and layoffs. AGC Biologics will be at BIO International to discuss their capabilities in drug production.
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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Intellia reported an adverse event in its gene therapy trial, causing its stock to drop, adding to existing safety concerns in gene therapy. Analysts downplayed the event, but patient deaths in other trials have raised red flags.## Moderna lost a $760 million bird flu vaccine contract amid uncertainties surrounding its COVID-19 vaccine. ## Other news includes Iteos closing down after a failed trial, Merck and Daiichi Sankyo pulling a lung cancer filing, and Novo opposing pharma tariffs.## AGC Biologics will be at Bio International to discuss their capabilities in drug production. ## Additional stories cover Rocket's gene therapy hold, Biogen's strategy shift, and AbbVie's staff cuts.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Former Chinook board member, Rouzbeh Haghighat, has been indicted for insider trading related to Novartis' $3.2 billion acquisition of the company. Despite this scandal, pharma R&D spending increased in 2024, climbing 1.5% across the global pharmaceutical sector. The acquisition of SiteOne by Lilly follows Vertex into the non-opioid pain space, providing diversification for Lilly, which has been focusing on obesity and diabetes treatments. Meanwhile, AbbVie's Allergan cuts over 200 staff after a botched marketing campaign, and Inflarx axes a rare skin disease study due to disappointing late-stage data.AGC Biologics will be at Bio International in Boston to showcase their global capabilities in drug production. Vaccine overhaul, rocket grounding, and drug price transparency are also highlighted in the latest news. Biogen's strategy for Zurzuvae shifts as obstetricians/gynecologists rise to the front lines. Drug price transparency in the US is discussed as being easier said than done. Additionally, Rocket's gene therapy for Danon disease is on hold after a patient death, and four biotechs are facing uncertainty in the COVID-19 vaccine landscape.Global pharmaceutical companies are increasing their research and development spending despite political and economic challenges. Biogen is shifting its strategy for the drug Zurzuvae as obstetricians and gynecologists become more involved. Drug price transparency in the US is still a challenge, despite efforts to increase transparency. Trilink has introduced a new poly(A) tail modification to enhance protein expression.In other news, a former Chinook board member has been indicted for insider trading, Trump has appointed Dr. Oz to lead drug pricing negotiations, and Lilly is following Vertex into non-opioid pain treatment with a SiteOne acquisition. Sanofi has purchased Vigil for $470 million to reignite an Alzheimer's target.
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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.A patient death has led to the halt of Rocket's gene therapy trial for Danon disease, due to complications from an acute systemic infection. This incident highlights the unpredictable nature of gene therapies and may pose challenges for investment in the field. On the other hand, mRNA technology has been both helped and hindered by the COVID-19 pandemic. While the pandemic has increased interest and funding in mRNA research, vocal skeptics of COVID-19 vaccinations have negatively impacted the reputation of mRNA technology. Despite this, some see promise in mRNA for therapeutics in cancer and rare diseases.In other news, Prothena is considering business options after a failed phase III trial, and a new biotech company has been launched to focus on neuro diseases. Additionally, AGC Biologics will be at Bio International to showcase their capabilities in protein biologics and advanced therapies.mRNA technology played a significant role in combating COVID-19, but is now facing scrutiny due to vaccine skeptics and cuts in government funding for research. Despite this, the pandemic accelerated advancements in mRNA therapeutics for cancer and rare diseases. The lack of FDA-approved treatments for rare diseases, particularly in children, highlights a critical need for innovation in this area. The American Association for Cancer Research's annual conference will unveil data that could impact cancer treatment, while the future of vaccine development faces challenges amidst regulatory changes and funding issues. Additionally, advancements in cell and gene therapy are on the horizon. Suggestions for coverage topics in the biopharma industry are welcomed.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The biopharma industry is currently facing challenges such as tariff threats and regulatory upheaval. The market has been described as 'moribund' with the need for companies to survive in these tough times. Recent top stories include biotech's struggle with investor pullback due to new tariffs, HHS vaccine requirements sparking controversy, and layoffs in major biopharma companies. AGC Biologics will be at Bio International to showcase their global capabilities in drug production. FDA and NIH are shifting away from animal research, China remains a key source for new drugs despite tariffs, and the top highest-paid pharma CEOs are highlighted. The importance of understanding Trump's MFN executive order and the most active corporate VCs in pharma are also discussed.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.A court has halted the Trump administration's plans to reduce and lay off employees in government agencies, citing a lack of authority. Meanwhile, a report called "Make American Healthy Again" criticizes pharmaceutical lobbying, GLP-1s, and vaccines. The report also addresses rising autism rates and over-medication of children. Bio-Rad is redefining antibody discovery with their Pioneer Antibody Discovery Platform.In other news, Merus' bispecific shows promise in head-and-neck cancer, while Congress narrowly passes a tax bill with changes to IRA penalties and negotiation exemptions for orphan drugs. The FDA vaccine advisors agree on a COVID-19 vaccine as a new framework looms, and GSK wins expansion for Nucala after an FDA delay. Lilly expresses concern as CMS leaves obesity drugs out of Medicare coverage, and Sanofi acquires Vigil for $470 million upfront. And that's all for today's updates in the pharmaceutical and biotech world. Stay tuned for more essential news in our next episode.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Sanofi has acquired Vigil for $470 million upfront, sparking interest in the Alzheimer's target Trem2 following previous failures. The FDA is encouraging states to import drugs from Canada to alleviate drug shortages. In other news, the FDA has asked Pfizer/BioNTech and Moderna to add myocarditis risk warnings to their COVID-19 vaccine labels. Lilly is disappointed by CMS's decision to exclude obesity drugs from Medicare coverage, and Canada is taking steps to protect its drug supply. Bio-rad is advancing biotherapeutic antibody discovery with its Pioneer antibody discovery platform. Additional news includes Pfizer's Talzenna expansion not receiving FDA advisory committee support, Eikon cutting its workforce by 15%, and the Southeast's growing life sciences sector. Stay tuned for more updates in the Pharma and Biotech world.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Moderna has withdrawn its application for a combination flu and COVID-19 vaccine after discussions with the FDA. The vaccine had shown efficacy in eliciting antibodies, but the company decided to pull the application. In the biotech market, executives from NextGen companies discussed strategies for surviving in what they described as a "moribund" market during a webinar. Biospace's nextgen companies are thriving in a challenging biotech market. Executives discuss survival strategies in the webinar "Are We There Yet?" Pfizer's $6 billion China deal stands out in a competitive market, with Novartis' $4 billion partnership following closely. Biopharma companies are facing pressure to cut assets early due to rising development costs and regulatory hurdles. Lotte Biologics offers specialized end-to-end services at its ADC facility in Syracuse, NY. Other top stories include the FDA's new risk-based approach to COVID-19 vaccines, Genentech's investment in Orionis, and Bio-Rad's new center for excellence for biotherapeutic antibody discovery. Roche's Genentech recently did not win adcomm backing for an expansion. Pfizer has made a deal in China, and RFK claims ignorance about HHS research cuts during a hearing. The top 5 most active corporate VCs in pharma are also highlighted. Additionally, upcoming events and job opportunities in the biotech industry are featured.In conclusion, the biotech market is presenting challenges for companies, but there are opportunities for growth and strategic partnerships. Stay tuned for more updates on regulatory changes, investment deals, and industry trends in the world of Pharma and Biotech. Thank you for listening to Pharma and Biotech daily.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a $6 billion bet on acquiring 3SBio's PD-1/VEGF antibody, despite being a late entrant to the space. This deal comes after Pfizer's partnership with Summit Therapeutics, causing some confusion about the pharma company's overall strategy. Meanwhile, the success of a CRISPR baby has highlighted the lack of FDA-approved treatments for the 15 million children with rare diseases. Most rare conditions do not even have a treatment pipeline. Bio-Rad is redefining antibody discovery through their Pioneer™ Antibody Discovery Platform, which accelerates programs and identifies clinical-quality candidates with industry-leading timelines. FDA Commissioner Marty Makary has expressed support for psychedelic therapies for neuropsychiatric conditions, noting significant benefits for patients. The most favored nation executive order issued by Trump may face legal challenges and unintended consequences for the healthcare sector and patient access. Overall, these developments in the pharmaceutical and biotech industries highlight ongoing challenges and opportunities in drug development and treatment for rare diseases.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Regeneron has acquired ownership of 23andme for $256 million, promising to comply with consumer privacy policies. Makary's proposed rare disease pathway has sparked hope but raised questions among experts. At the American Society of Gene and Cell Therapy meeting, the first personalized in vivo CRISPR therapy was reported. The FDA has cleared the first Alzheimer's blood test, potentially boosting uptake of Alzheimer's disease therapies. Bio-Rad's new Center for Excellence is redefining antibody discovery with their Pioneer Antibody Discovery Platform. FDA regulations are unlikely to save money for the industry, and Applied Therapeutics' rare disease treatment has failed in late-stage trials. The memory gap in forgotten diseases is making a dangerous comeback, and Novo CEO's sudden exit has raised concerns among analysts.FDA Commissioner Marty Makary's proposal for a 'conditional approval' pathway for rare diseases has sparked hope among biopharma companies, but experts are raising concerns about safety, access, and liability due to a lack of details. The FDA and NIH are accelerating the shift away from animal research, which has raised questions about safety and implementation. Meanwhile, FDA cuts have led to chaos in planning for upcoming advisory committee meetings. The Trump administration's efforts to slash regulations may not necessarily benefit the industry as anticipated. Sarepta is seeking to strengthen its case for Elevidys with data in older kids, while other companies such as Incyte and Lilly are making progress with their drug approvals. Overall, the biopharma industry is facing challenges and uncertainties in navigating the evolving regulatory landscape.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Novo Nordisk CEO Lars Fruergaard Jorgensen is set to depart as the Danish pharma company's shares have been on a decline. During Jorgensen's eight-year tenure, the company saw significant growth in sales, profits, and share price, nearly tripling in value. However, since mid-2024, the shares have dropped by half in just one year. Jorgensen's departure comes as a surprise given the company's previous success under his leadership.
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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.At a recent U.S. Senate hearing, Health and Human Services Secretary was questioned about cuts being made to the department and his stance on endorsing the measles vaccine during a growing outbreak. The hearing was tense at times, with RFK Jr. firm on supporting the cuts but wavering on his stance on the MMR vaccine. AbbVie's ADC received accelerated approval for lung cancer treatment, FDA delays decision on Biohaven's application, and chaos ensues at the FDA's advisory committee planning office after workforce cuts. Sino Biological offers solutions for autoimmune disease research, with reagents for nearly 50 diseases. Novo Nordisk has invested $2.4 billion in a new oral obesity drug through a deal with Septerna, aiming to catch up with competitors in the oral weight loss space. AbbVie has committed $335 million upfront in a partnership with Adarx Pharmaceuticals for siRNA research, while GSK has abandoned a TIGIT therapy and instead acquired rights to a liver drug from Boston Pharmaceuticals for potential $2 billion deal. This news highlights the ongoing developments and investments in the pharmaceutical industry.
- Visa fler
