FDA authorizes Pfizer's coronavirus vaccine for younger teens

The Latest

• 

  Deep Dive

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

  In a major policy shift, the Biden administration said it will support waiving vaccine patent rights amid concerns of unequal access globally.

  UPDATED: May 7, 2021 at 12:04 p.m.

  Pharma

• 

  Sponsored by Koneksa Health

  Wearables for actigraphy measures in clinical trials

  It's now possible to gather far more data, more often, more objectively, and more easily than ever before, and, with the appropriate choice, broadly expedite clinical trials utilizing actigraphy measurements.

  Clinical Trials

• 

  Biogen looks to build better gene therapies through latest deal

  The collaboration with Capsigen hands Biogen rights to a technology that could support the development of gene therapies for central nervous system and neuromuscular disorders.

  Gene Therapy

• 

  Amgen asks FDA for approval of key asthma drug

  Tezepelumab is one of Amgen's top experimental medicines and a U.S. OK would help its efforts to offset revenue declines from its aging blockbusters.

  Marketing

• 

  Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

  The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.  

  Pharma

• 

  Pharma erupts as Biden administration backs waiver of vaccine patent rights

  The shift in U.S. policy might not undermine future research as the drug industry claims. Easing patent protections, though, isn't likely to translate to an immediate boost in vaccine supply.

  Pharma

• 

  Dyno, in demand for its gene therapy work, raises $100M for fast expansion

  After inking three pharma deals within a year of launching, the Harvard spinout has the backing of Andreessen Horowitz and several other top investors.

  Biotech

• 

  CSL closes deal for UniQure gene therapy in hopeful sign for M&A

  Completion of the buyout eases concerns the arrangement might be held up by the FTC, which has signaled it will step up scrutiny of life sciences deals.  

  Biotech

• 

  ICER, unconvinced by Biogen data, suggests low price for Alzheimer's drug

  The influential watchdog group found the evidence supporting aducanumab "insufficient" and suggested the drug would be cost effective at up to $8,300 per year, well short of what some analysts are predicting.

  Drug Pricing

• 

  Roger Perlmutter, former Merck research chief, resurfaces to lead a small biotech

  Months after leaving his post as Merck's top scientist, Perlmutter has become CEO of Eikon Therapeutics, which plans to use Nobel Prize-winning microscope technology to discover new drugs.

  Biotech

• 

  Esker, a new biotech startup, launches with plans to make targeted immune drugs

  Led by a former MyoKardia executive, Esker Therapeutics is developing a drug that could eventually compete with one of Bristol Myers Squibb's most closely watched candidates.

  Biotech

• 

  Adagio, flush with cash, launches large study of next-gen COVID-19 antibody

  The privately held biotech believes its drug might treat or prevent infections from existing variants and future coronavirus strains, which could make it a competitor to marketed therapies from Regeneron and Eli Lilly. 

  Biotech

• 

  Pfizer forecasts $26B in coronavirus vaccine revenue this year

  The sum is $11 billion higher than Pfizer had estimated in February and, if realized, would make the vaccine the highest grossing pharmaceutical product by revenue in a single year.

  Pharma

• 

  A worrisome side effect stalls a closely watched multiple myeloma drug

  Pfizer halted a key trial of one of the most advanced bispecific antibody drugs in development for the blood cancer after several cases of peripheral neuropathy. 

  UPDATED: May 4, 2021 at 12:01 p.m.

  Clinical Trials

• 

  Sage braces for make-or-break depression data

  The biotech's latest earnings call focused less on revenue and more on an experimental drug for depression that's close to having important study results.

  Biotech

• 

  Roivant valued at $7B in blank-check merger, bucking SPAC slowdown

  Vivek Ramaswamy's unusual biotech holding company will go public through a deal with Montes Archimedes Acquisition Corp. that nets Roivant $611 million.

  Biotech

• 

  Sarepta's second-gen Duchenne drug shows signs of topping its first

  An experimental Duchenne drug developed with a newer technology may be more potent than Sarepta's marketed treatment Exondys 51. But early data also brought new safety concerns.

  Biotech

• 

  Avrobio changes course after FDA closes path for speedy gene therapy approval

  The FDA recently converted its clearance for a standard Fabry treatment to a full approval, complicating Avrobio's plans to seek an accelerated OK for its rare disease therapy. 

  Biotech

• 

  FDA faces tough choice after panel backs speedy cancer drug approvals

  FDA advisers last week recommended maintaining four of six accelerated immunotherapy approvals despite negative results in confirmatory testing.

  Pharma

• 

  Emergent CEO defends company from criticism of error that ruined vaccine doses

  The company expects to respond within days to a long list of findings FDA officials made in an inspection of Emergent's Baltimore plant earlier this month.

  Manufacturing

• 

  Denying problems, AstraZeneca says US coronavirus vaccine filing due within weeks

  Five weeks after AstraZeneca reported positive trial results, the company has still not applied to the FDA for authorization, saying the size of the dataset has slowed its submission.

  Pharma

• 

  Merck, GSK vaccine sales hit by pandemic as competitors' business booms

  Both companies blamed the impact of COVID-19 on sharp declines in sales of their shingles, pneumonia and HPV shots. 

  Pharma

• 

  FDA gives first citation to biotech for failure to report clinical trial details

  The agency threatened to fine Acceleron for not posting study results to clinicaltrials.gov. Whether the action is a sign of a larger crackdown is unclear.

  FDA

• 

  Moderna plans to triple coronavirus vaccine production next year

  The biotech aims to double capacity at plants in Switzerland and Spain, and by 50% at U.S. sites. The total number, however, will depend on the mix of primary and booster doses.

  Manufacturing

• 

  A serious side effect puts a biotech's eye gene therapy in limbo

  Adverum Biotechnologies has unmasked a Phase 2 study in which a trial participant suffered severe inflammation and vision loss — a finding that could threaten the program’s future in multiple eye diseases.

  Biotech

• 

  Wall Street fears Amgen's tough first quarter is just the start

  Product sales fell by 5% in the first quarter, keeping the pressure high for Amgen to deliver on expectations for its KRAS cancer drug Lumakras.

  Biotech

More stories