Aimmune Awarded First FDA Approval for a Peanut Allergy Therapy

Posted by |2020-02-03T02:30:07-07:00January 31st, 2020|

An Aimmune Therapeutics drug developed to treat peanut allergy won FDA approval late Friday—the first time the agency has approved an oral immunotherapy for a food allergy. The Aimmune (NASDAQ: AIMT) drug, Palforzia, was developed to desensitize patients to peanuts. The FDA decision covers patients between the ages of 4 and 17 who have a […]

Moderna Adds Takeda’s Melanie Ivarsson as Chief Development Officer

Posted by |2020-01-30T15:56:58-07:00January 30th, 2020|

Moderna (NASDAQ: RNA) named Melanie Ivarsson as its chief development officer. Ivarsson was most recently vice president, head of clinical operations at Takeda Pharmaceuticals (NYSE: TAK). Her previous experience includes serving as senior director, head of clinical strategy and operations at Pfizer (NYSE: PFE), and in roles within the early clinical development group at Eli Lilly […]

Annovis Bio Gets $12M in IPO to Target Trio of Neurotoxic Proteins

Posted by |2020-01-29T16:41:38-07:00January 29th, 2020|

A Philadelphia-area biotech is developing therapies for neurodegenerative diseases it says have the potential to perform better than others by targeting multiple proteins involved in the brain’s breakdown. Now the company, Berwyn, PA-based Annovis Bio, has raised $12 million in an initial public offering to advance clinical development of its lead therapy in patients with […]

Histogen, Timber Pharma Plan Reverse Mergers to Join Public Markets

Posted by |2020-01-28T20:25:18-07:00January 28th, 2020|

Two privately held biotechs on Tuesday announced plans for reverse mergers, transactions that provide a faster route to go public than a conventional IPO and also give struggling public companies a chance to recoup some value for their shareholders. San Diego regenerative medicine company Histogen announced an agreement to gain a Nasdaq listing through a […]

Flagship Adds Fertility-Focused Ohana Biosciences to Biotech Family

Posted by |2020-01-27T17:00:18-07:00January 27th, 2020|

About 7 million couples in the US have difficulty getting or staying pregnant. A new biotech is using insights into the biology of male reproductive cells—the sperm that must meet its female equivalent, an egg cell, for fertilization to occur—to develop products meant to make assisted reproductive technologies such as in vitro fertilization (IVF) more […]

Beam Therapeutics Promotes Giuseppe Ciaramella to President

Posted by |2020-01-27T02:30:07-07:00January 24th, 2020|

Beam Therapeutics has promoted Chief Scientific Officer Giuseppe “Pino” Ciaramella to president. He will continue to serve as the Cambridge, MA, biotech’s CSO, a role he has held for nearly two years. Before joining Beam, Ciaramella was the CSO of Moderna (NASDAQ: MRNA). His experience also includes positions at AstraZeneca (NYSE: AZN) and Boehringer Ingelheim. […]

Epizyme’s Soft Tissue Cancer Drug Granted Speedy FDA Approval

Posted by |2020-01-23T17:19:40-07:00January 23rd, 2020|

Epizyme won accelerated FDA approval Thursday for a drug developed to treat the rare cancer epithelioid sarcoma (ES). The regulatory decision for the Epizyme (NASDAQ: EPZM) drug, tazemetostat (Tazverik), covers patients 16 or older whose ES has advanced or spread and is not eligible for surgical treatment. The drug is now the first FDA-approved treatment […]

FDA Flags Risk of Infection, Kidney Damage for Sarepta Duchenne Drugs

Posted by |2020-01-22T13:23:00-07:00January 22nd, 2020|

[Updated 7:25 p.m. See below.] Safety concerns stymied Sarepta Therapeutics’ attempt to win FDA approval last August for golodirsen (Vyondys 53), its second Duchenne muscular dystrophy drug. But an appeal of the decision led to a surprise reversal by the regulator last month, with little explanation why. Details are now surfacing about the safety risks […]

After Ending Cancer Drug Program, Halozyme Predicts Profits in 2020

Posted by |2020-01-21T17:48:41-07:00January 21st, 2020|

Halozyme suffered a setback in November when its investigational pancreatic drug failed a Phase 3 clinical trial, but its CEO says the biotech’s drug delivery technology will make the company profitable as early as the second quarter of this year. The San Diego-based company’s technology, called Enhanze, allows some drugs traditionally given intravenously over hours […]

Revolution Medicines Maps Out an IPO to Reach Cancer’s Frontiers

Posted by |2020-01-21T02:30:08-07:00January 17th, 2020|

Cancer research has revealed proteins known to play a role in the disease, but with no known way of stopping what they do. In pharmaceutical parlance, they’re “undruggable.” Revolution Medicines is trying to drug the undruggable with small molecules that block the signaling pathways these proteins use to help cancer grow and thrive. With one […]

BioCryst Pharma Promotes Charles Gayer to Chief Commercial Officer

Posted by |2020-01-16T15:21:22-07:00January 16th, 2020|

BioCryst Pharmaceuticals (NASDAQ: BCRX) has promoted Charles Gayer to chief commercial officer. Gayer joined the Durham, NC-based drug developer in 2015 as vice president of global strategic marketing. His experience also includes positions at Talecris and GlaxoSmithKline (NYSE: GSK). BioCryst is preparing for the expected commercial launch of berotralstat, a drug that has been submitted […]

Disarm Therapeutics Names Scott Holmes Chief Financial Officer

Posted by |2020-01-15T16:22:15-07:00January 15th, 2020|

Disarm Therapeutics has appointed Scott Holmes to serve as its chief financial officer, the same position he held most recently at Kiadis Pharma. Before working at Kiadis, Holmes was the CFO of Keryx Biopharmaceuticals. Cambridge, MA-based Disarm is developing drugs neurodegenerative disease drugs that target a protein called SARM1.
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