FDA documents show how controversial Alzheimer's drug decision was reached

The Latest

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  Deep Dive

  Record numbers of biotechs are going public. Here's how they're performing.

  Four biotech companies, including Bayer-backed cell therapy developer Century Therapeutics, priced IPOs on Thursday, bringing the year's total to 44.

  UPDATED: June 17, 2021 at 9:05 a.m.

  Biotech

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  Merck says Keytruda extends survival in cervical cancer study

  Results from a Phase 3 study could help Merck secure a full approval for use of Keytruda in the tumor type, potentially extending the therapy's edge over rival therapies.

  Pharma

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  Long-term Zolgensma data backs up gene therapy's use in youngest patients

  With more and more states screening for SMA at birth, the study results are important for assessing Zolgensma's benefits when given very early on.

  Pharma

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  GSK, Vir build case for COVID-19 antibody drug with new study data

  Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19.

  Clinical Trials

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  Bristol Myers partners with Eisai in $650M deal for targeted cancer antibody

  The U.S. drugmaker is the latest to invest large sums of money in antibody-drug conjugates, following recent deals by Gilead, Merck and AstraZeneca.

  Pharma

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  Deep Dive

  A first-of-its-kind Alzheimer's drug raises heavy questions around who will and won't get it

  Biogen priced its newly approved medicine Aduhelm at an average cost of $56,000 a year, adding affordability to other barriers patients may face. 

  Marketing

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  US to invest $3B in research quest for COVID-19 pill

  Compared to vaccines, development of antiviral drugs for the coronavirus has progressed more slowly, although data are expected soon from Merck, Pfizer and Atea. 

  Clinical Trials

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  Trial failure dashes Biogen hopes for next Alzheimer's drug

  Days after Aduhelm's approval, Biogen said an experimental drug that works in a different way didn't help patients, leading the company to stop research.

  Biotech

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  CureVac vaccine disappoints in key study amid 'unprecedented' spread of variants

  The German biotech’s shot appeared less effective than other mRNA vaccines at preventing COVID-19. But it's unclear whether differences between the shots, or exposure to more elusive variants in testing, are the cause.

  UPDATED: June 17, 2021 at 11:37 a.m.

  Biotech

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  Gene editing biotech Verve to raise $267M in large IPO

  Capitalizing on investor interest in gene editing, the high-profile startup has secured one of the richest biotech initial public offerings priced this year.

  Biotech

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  Deep Dive

  Coronavirus vaccines are rolling out quickly. Here's where the pipeline stands.

  Disappointing study results from CureVac are a reminder of the difficulty of vaccine development and raise questions about why its mRNA shot doesn't appear as effective as Pfizer's and Moderna's. 

  UPDATED: June 17, 2021 at 10:25 a.m.

  Pharma

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  FDA approves Blueprint cancer drug for use in rare blood disease

  The agency's decision makes available a new treatment option for patients with advanced systemic mastocytosis, boosting the biotech in the process.

  Biotech

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  Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval

  The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.

  FDA

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  Regeneron antibody cuts risk of COVID-19 death in UK study

  The biotech said it will seek an expanded FDA clearance after results from the RECOVERY trial showed its antibody can lower mortality among certain hospitalized COVID-19 patients.

  Clinical Trials

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  Sage antidepressant succeeds in key study, but data raise questions

  Zuranolone, a drug that's crucial for Sage's future and the focus of a multi-billion dollar bet by Biogen, could be headed for a regulatory review. But new trial results are more mixed than the overall outcome suggests. 

  UPDATED: June 15, 2021 at 10:39 a.m.

  Biotech

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  Biogen gene therapy deal has yet to bear fruit

  Another gene therapy from Nightstar Therapeutics, which Biogen bought for $800 million in 2019, has failed in a key clinical study.

  Biotech

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  Former FDA chief Hahn joins venture firm that launched Moderna

  Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors. 

  Pharma

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  CRISPR, with new partner, to develop gene editing therapies for ALS, nerve disorder

  A deal with biotech startup Capsida, which recently raised $140 million, gives CRISPR access to a Caltech technology that aims to improve the delivery of genetic medicines.

  Deals

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  Novavax says vaccine 90% effective against COVID-19 in large trial

  Highly anticipated results from a Phase 3 study testing the biotech company's shot showed it to be strongly protective and safe, a potential boon for the world's vaccination efforts.

  UPDATED: June 14, 2021 at 9:27 a.m.

  Clinical Trials

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  GSK pays iTeos $625M to join race for new type of cancer immunotherapy

  The British drugmaker has become the latest large pharmaceutical company to make a sizable investment in a drug targeting TIGIT, following deals from Bristol Myers Squibb, Gilead and others.

  Deals

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  Moderna founder raises another $2B to fuel new startups

  Flagship Pioneering reopened one of its funds in April, quickly raising fresh cash for new biotech investments.

  Biotech

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  As trials progress, FDA weighs COVID-19 vaccine authorizations for children

  An advisory panel could not reach consensus on how long or large trials in young children should be. Some experts argued falling infection rates might mean vaccination of kids under 12 is unnecessary.

  Pharma

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  Blood disease treatment from CRISPR, Vertex shows promise in more patients

  The latest results from the companies' trials give support to hopes that CRISPR gene editing could functionally cure sickle cell disease and beta thalassemia.

  Biotech

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  'The lights are no longer green': Antitrust regulators reassess pharma deals

  The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues to where they may look next.

  Pharma

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  Vertex stops work on second rare disease drug after study results disappoint

  The biotech said its drug for alpha-1 antitrypsin deficiency wasn't potent enough to advance into further testing, but plans to move others into clinical trials next year.

  UPDATED: June 11, 2021 at 10:28 a.m.

  Biotech

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