Biotech: Page 59
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National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
GSK claims first positive Phase 3 result for an RSV vaccine
The British drugmaker now plans to seek approval of what could be the first preventive shot for the common lung infection. However, Pfizer, Johnson & Johnson and Moderna are close behind.
By Jonathan Gardner • June 10, 2022 -
Kena Betancur via Getty Images
Forbion raises $500M to back growing biotechs amid industry slump
The European venture firm’s latest fund will open up a new source of investment at a time companies are struggling to go public or hold their value.
By Delilah Alvarado • June 10, 2022 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Alnylam follows rivals with new study results for kidney disease drug
An experimental medicine the company is developing with Regeneron has shown early promise treating IgA nephropathy, a disease that’s become a competitive target among drugmakers.
By Jonathan Gardner • June 9, 2022 -
Courtesy of Novavax, Australian Broadcasting Corporation
FDA advisers back Novavax's latecomer COVID-19 vaccine
Outside experts debated the shot's safety profile and its efficacy versus the omicron variant but ultimately supported the vaccine, which is made using more traditional technology than Pfizer's and Moderna's.
By Jonathan Gardner • Updated June 7, 2022 -
Biotech Athersys to lay off 70% of staff in cost-cutting effort
The stem cell therapy company said the restructuring is meant as a first step toward making it "more attractive" to potential financial and strategic partners.
By Delilah Alvarado • June 6, 2022 -
Sarah Silbiger via Getty Images
FDA extends review of Amylyx ALS drug, delaying approval decision
The agency said it wanted more time to assess additional clinical trial data submitted by Amylyx, and set a new decision date of Sept. 29 for the closely watched treatment.
By Ned Pagliarulo • June 3, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers bets $4B on Turning Point and its targeted cancer drugs
While priced at a significant premium, the deal values Turning Point well below its peak valuation last year, a potential sign biotechs might be adjusting their expectations amid the sector's downturn.
By Jonathan Gardner • Updated June 3, 2022 -
Permission granted by Roche
Roche gambles $125M on a sliding biotech's cancer drug
Months after early results from Repare Therapeutics' drug disappointed analysts, the Swiss pharma has acquired rights, betting it may prove useful in combinations with other treatments.
By Kristin Jensen • June 2, 2022 -
Permission granted by Tessera Therapeutics
Former AbbVie executive Severino joins Flagship-backed startup as CEO
Severino left the pharma company in April after eight years as its chief scientist and then president. He'll lead Tessera Therapeutics, a well-funded genetic medicine startup.
By Ned Pagliarulo • June 2, 2022 -
Permission granted by Upstream Bio
Upstream Bio, a richly funded startup, reveals its lead drug and research plans
Backed by $200 million in funding and led by biotech veteran Samantha Truex, Upstream is developing a clinical-stage inflammatory disease drug acquired from Astellas last year.
By Ned Pagliarulo • June 2, 2022 -
Permission granted by Biogen
Sage, Biogen drug meets goal in postpartum depression study
The results will help support an application for FDA approval, which the companies plan to submit early next year. They are already seeking an OK for their treatment in major depressive disorder.
By Ned Pagliarulo • June 1, 2022 -
Sarah Silbiger via Getty Images
BioMarin delays planned FDA filing for hemophilia gene therapy
The California biotech now expects to resubmit its approval application to the FDA by the end of September, the latest regulatory setback for its closely watched treatment.
By Ned Pagliarulo • May 31, 2022 -
Retrieved from National Cancer Institute on September 27, 2019
Mirati matches Amgen with updated data for KRAS-blocking cancer drug
Fresh study results showed similar rates of response and progression-free survival with Mirati's experimental adragasib as with Amgen's approved Lumakras. The new data might raise safety questions, however.
By Ned Pagliarulo • Updated May 27, 2022 -
Former Editas CEO Bosley joins UK venture capital firm
Bosley, who once led the CRISPR gene editing biotech, will become a venture partner at Advent Life Sciences, which backs a range of early-stage drug companies.
By Ned Pagliarulo • May 26, 2022 -
A cash-strapped biotech winds down operations
With the market for biotech stocks constrained, Genocea Biosciences plans to delist from Nasdaq and lay off the its remaining employees.
By Kristin Jensen • May 25, 2022 -
Responding to outbreak, Moderna starts early work on monkeypox vaccine
One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus.
By Jonathan Gardner • May 24, 2022 -
Springworks shares fall despite drug trial's success
The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10%.
By Ned Pagliarulo • May 24, 2022 -
Elizabeth Regan/BioPharma Dive
Concert drug helps regrow hair in study, boosting shares
There are no treatments specifically approved for alopecia areata. Concert follows Pfizer and Eli Lilly in reporting positive late-stage results for drugs the companies are developing for the autoimmune disorder.
By Ned Pagliarulo • May 23, 2022 -
Westend61 via Getty Images
Sponsored by GoodRxCommon barriers to patient engagement: What's your strategy?
As with treatment, and even adherence, there is no 'one size fits all' when it comes to patient engagement.
May 23, 2022 -
Getty / Edited by BioPharma Dive
PTC's first gene therapy gains European regulator's backing
The brain-infused treatment for a rare neurological disease would be one of only three gene therapies commercially available in the EU. PTC plans to ask for FDA approval later this year.
By Jonathan Gardner • May 20, 2022 -
National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
Trial setback casts doubt on a biotech's respiratory virus drug
As vaccines for respiratory syncytial virus progressed, Enanta used its hepatitis C know-how to develop an antiviral pill. Yet data in lower-risk patients raise questions of whether it can work.
By Jonathan Gardner • May 19, 2022 -
Permission granted by Odyssey Therapeutics
Cancer drug startup draws former Vertex CEO to board
Jeffrey Leiden will team up again with biotech entrepreneur Gary Glick, this time as board chairman of Glick's new company, the recently launched Odyssey Therapeutics.
By Kristin Jensen • May 19, 2022 -
Courtesy of Vertex Pharmaceuticals
Vertex adds to Boston expansion with plans for new site
The addition, which will be located next to the company's newly dedicated cell and gene facility, could make Vertex the largest biotech by square footage in the city.
By Kristin Jensen • May 18, 2022 -
Maddie Meyer via Getty Images
Moderna may seek to claw back payments to ex-CFO
Jorge Gomez, who lasted one day on the job before being ousted over an investigation at his former company, is owed $700,000 — money Moderna says it can recoup if wrongdoing is proven.
By Maura Webber Sadovi • May 17, 2022 -
Danielle Ternes/BioPharma Dive
Gene therapy safetyScientists home in on cause of Duchenne gene therapy side effect
An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.
By Jonathan Gardner • Updated May 18, 2022
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