Sanofi, Pfizer & Bristol Drugs Among the 12 Approvals to Look Out for in Q4

Posted by |2020-11-30T02:30:10-08:00October 15th, 2020|

The end of the year should see a flurry of new products reaching the market to break new commercial ground or shake up their respective therapeutic areas. Here, Scrip takes a look at 12 of the more interesting approvals expected in the coming months, with the help of analysts at Biomedtracker. Supernus Pharmaceuticals’ SPN-812 Indication: […]

Codiak Bio’s IPO Brings In $82M as Exosome Clinical Trials Begin

Posted by |2020-10-14T06:59:33-08:00October 14th, 2020|

Codiak BioSciences now has $82.5 million to fund clinical tests of a new class of medicines based on exosomes, tiny bubbles formed by cells that the company harnesses to carry therapeutic cargo. Late Tuesday, Codiak priced its offering of 5.5 million shares at $15 apiece, the midpoint of its projected $14 to $16 per share […]

Roche Enlists Dyno to Bring AI to Next-Generation Liver, CNS Gene Therapies

Posted by |2020-10-14T02:00:31-08:00October 14th, 2020|

Roche made a splash with its acquisition of Spark Therapeutics, whose Luxturna, a gene therapy for an inherited form of vision loss, was the first such therapy to win FDA approval. Now the Swiss pharmaceutical giant is looking to bolster its capabilities in liver and central nervous system (CNS) disorder gene therapies and it’s turning […]

SQZ Biotech Lines Up an IPO on the NYSE to Fund Cell Therapy R&D

Posted by |2020-10-12T13:39:21-08:00October 12th, 2020|

SQZ Biotechnologies, which already has an alliance with Roche focused on developing new cancer cell therapies, is now looking to sell shares to the public to finance its research of potential new treatments for both cancer and infectious disease. In paperwork filed with securities regulators late last week, SQZ set a preliminary $75 million goal […]

FDA Panel Vote Weighs in Favor of Alkermes Psych Drug, With Caveats

Posted by |2020-10-09T17:03:11-08:00October 9th, 2020|

An Alkermes antipsychotic treatment designed to offer the benefits of a commonly prescribed medicine, but without the weight gain side effect, won the backing of an FDA advisory committee on Friday. But even some of the panel members who supported the drug qualified their votes, expressing concern about what the drug could mean for patients […]

FDA Panel Vote Weighs in Favor of Alkermes Psyche Drug, With Caveats

Posted by |2020-10-11T03:30:09-08:00October 9th, 2020|

An Alkermes antipsychotic treatment designed to offer the benefits of a commonly prescribed medicine, but without the weight gain side effect, won the backing of an FDA advisory committee on Friday. But even some of the panel members who supported the drug qualified their votes, expressing concern about what the drug could mean for patients […]

Biogen’s AdComm Meeting Will Test FDA’s “Substantial Evidence” Flexibility

Posted by |2020-10-08T11:16:37-08:00October 8th, 2020|

A US Food and Drug Administration advisory committee meeting on Biogen, Inc.’s Alzheimer’s drug aducanumab will offer some insight into the amount of flexibility the agency and its external experts are willing to exercise for neurodegenerative diseases with high unmet need, particularly in the wake of a December 2019 guidance document on the quantum and […]

Scribe Therapeutics Sets Out to Write CRISPR Gene Editing’s Next Chapter

Posted by |2020-10-08T03:30:07-08:00October 6th, 2020|

The first generation of CRISPR-based therapies showed how the technology can edit DNA, making genetic fixes to unwanted mutations. But those treatments use the CRISPR system as scientists found it in nature, which means it still has limitations when applied to humans, says Benjamin Oakes, CEO of Scribe Therapeutics. Scribe aims to develop gene-editing therapies […]

Bristol Myers to Buy MyoKardia, FDA-Ready Heart Disease Drug for $13.1B

Posted by |2020-10-05T08:43:34-08:00October 5th, 2020|

Bristol Myers Squibb is bolstering its cardiovascular drug lineup with a $13.1 billion deal to acquire MyoKardia, a company whose experimental therapy for a rare type of heart disease is on track for an FDA submission and is projected to become a blockbuster seller, if approved. According to financial terms announced Monday, Bristol (NYSE: BMY) […]

Bristol Myers’s Hirawat on Pipeline Progress, Clinical Trial Diversity

Posted by |2020-10-05T03:30:08-08:00October 2nd, 2020|

As the one-year anniversary of Bristol-Myers Squibb Company’s $74bn acquisition of Celgene Corporation approaches, Scrip spoke with chief medical officer Samit Hirawat about the big pharma’s achievements during a challenging period in which the COVID-19 pandemic threatened to derail clinical trials and a national spotlight on racial inequality shined a light on the industry’s lack […]

FDA Lifts Solid Bio Clinical Hold, Duchenne Study Cleared to Resume

Posted by |2020-10-01T08:42:47-08:00October 1st, 2020|

Solid Biosciences has answered the FDA’s outstanding questions about its Duchenne muscular gene therapy, clearing a clinical trial to now resume after patient complications last year led the agency to halt the study for a second time. Cambridge, MA-based Solid Bio (NASDAQ: SLDB) said Thursday that it expects dosing of patients in the Phase 1/2 […]