Latest Posts

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

  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... Read more »

  Alex Shimmings10/15/20

• Vertex Stops Test of Rare Disease Drug, Dimming Pipeline Prospects

  Vertex Pharmaceuticals is halting work on an experimental drug for a rare protein deficiency after safety problems were reported in Phase 2 testing.

  The study was evaluating the small molecule, VX-814, as a treatment for alpha-1 antitrypsin deficiency, which can lead... Read more »

  Frank Vinluan10/15/20

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

  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... Read more »

  Frank Vinluan10/14/20

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

  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... Read more »

  Frank Vinluan10/14/20

• Despite Phase 2 Failure, Gossamer Bio Sees a Path for Drug in Asthma

  Gossamer Bio’s lead drug, an experimental treatment for asthma and allergies, has failed in two mid-stage clinical trials but the biotech sees enough in the data to pursue further development in a severe form of asthma and it wants to talk... Read more »

  Frank Vinluan10/13/20

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

  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... Read more »

  Frank Vinluan10/12/20

• “Opioid Stacking” Concerns Lead FDA to Reject Avenue Therapeutics Drug

  An opioid that Avenue Therapeutics reformulated for treating post-surgical pain in hospital settings has been rejected by the FDA due to safety concerns.

  The Avenue (NASDAQ: ATXI) drug is an intravenous formulation of tramadol, an opioid that first reached the... Read more »

  Frank Vinluan10/12/20

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

  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... Read more »

  Frank Vinluan10/9/20

• Bio Roundup: CRISPR Kudos, Bristol Myers’s Buy, RNAi Alliance & More

  It’s October: a time of days growing shorter, leaves changing color, and phone calls in the wee hours that rouse scientists from slumber notifying them they’ve won the highest honor in their fields.

  This week, the 2020 Nobel Prize in physiology... Read more »

  Frank Vinluan10/9/20

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

  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,... Read more »

  Sue Sutter10/8/20

• In RNAi Move, Takeda Fronts $300M to Team Up on Arrowhead Liver Drug

  Arrowhead Pharmaceuticals’ gene silencing treatment for a rare liver disease will move through the regulatory process and potential commercialization with the muscle of Takeda Pharmaceutical behind it.

  Takeda (NYSE: TAK) has agreed to pay $300 million up front in a... Read more »

  Frank Vinluan10/8/20

• BIO Launches ‘Biotech Votes’ Campaign to Encourage Registration and Informed Voting

  Science is the way out of this pandemic—and scientific breakthroughs are on the ballot on November 3. To help you get ready for Election Day, BIO’s initiative Biotech Votes has resources to help you get registered and get informed.

  First, make... Read more »

  Editors10/8/20

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

  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... Read more »

  Frank Vinluan10/6/20

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• Federation Bio Bags $50M to Engineer New Approach to Microbiome Drugs

  Scientists at microbiome therapy developers often talk about the importance of community, how the bugs in our gut act in concert in addition to their individual roles. That’s important for microbiome health and for microbe-based therapies, says Emily Drabant Conley, CEO of... Read more »

  Frank Vinluan10/6/20

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

  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... Read more »

  Frank Vinluan10/5/20

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

  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... Read more »

  Mandy Jackson10/2/20

• Bio Roundup: MESO’s Miss, Pfizer’s Cancer Bet, Vaccine Promise & More

  Amid the bombast of Tuesday’s presidential debate, viewers caught some discussion about the response to the coronavirus pandemic and efforts to develop a COVID-19 vaccine. In the crosstalk, the president made an unsupported claim that we are weeks away from having... Read more »

  Frank Vinluan10/2/20

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

  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... Read more »

  Frank Vinluan10/1/20

• Genfit Restructuring Cuts Staff by 40%, Creates Two New Subsidiaries

  [Updated 10/1/2020. See below.] Genfit is halting all work on its lead drug in the fatty liver disorder nonalcoholic steatohepatitis (NASH) and implementing a corporate restructuring that will cut 40 percent of its staff, splitting the remaining workforce into... Read more »

  Frank Vinluan10/1/20

• Pfizer Pumps $200M Into CStone for Rights to PD-L1 Cancer Drug in China

  CStone Pharmaceuticals has touted its experimental drug sugemalimab as potentially the best in its class of cancer immunotherapies. Pfizer is placing a bet on that promise by making a $200 million equity investment in CStone for rights to that drug in... Read more »

  Frank Vinluan9/30/20

• With Phase 2 Data in Hand, Ovid Eyes Multiple Pivotal Trials for Epilepsy Drug

  Ovid Therapeutics and Takeda Pharmaceutical joined forces three years ago to develop a small molecule into a potential epilepsy drug. That research is starting to pay off as the companies now look ahead to pivotal studies testing that compound in several... Read more »

  Frank Vinluan9/30/20

• Orphazyme Stock Sale Reaps $83M as Neimann-Pick Drug Review Begins

  Orphazyme has fresh cash from the sale of shares in the US and Europe, which will support its lead rare disease drug through regulatory review and, if approved, a launch. But the drug fell short in key clinical trial measures, raising... Read more »

  Frank Vinluan9/29/20

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• Praxis Precision Medicines Leads Way as Three More Biotechs Prep IPOs

  Praxis Precision Medicines kept mostly quiet about its research on central nervous system disorder (CNS) drugs until May, when it emerged from stealth and revealed $100 million in cumulative financing. Now the company is aiming to raise about that amount... Read more »

  Frank Vinluan9/28/20

• Galecto Picks Up $64M as Plans for Fibrosis Clinical Trials Move Forward

  Had things turned out differently, scientists at Galecto might be watching their idiopathic pulmonary fibrosis drug candidate develop in the hands of a big pharmaceutical company. But Bristol Myers Squibb passed on its option to acquire Galecto leaving the biotech to... Read more »

  Frank Vinluan9/25/20

• Bio Roundup: Grail Acquisition, Libra’s Launch, Tau Trial Results & More

  In biotech, you can go home again. Four years ago, Illumina spun out cancer diagnostics startup Grail. This week, the gene sequencing giant announced it is acquiring Grail in an $8 billion cash and stock deal.

  Grail set out with the... Read more »

  Frank Vinluan9/25/20

• Combined Therapeutics Inc Wins $250,000 MilliporeSigma Advance Biotech Grant

  MilliporeSigma has awarded MIT spin-out Combined Therapeutics Inc. as the winner of its 2020 North America Advance Biotech Grant.

  Combined Therapeutics Inc (CTx) is an early stage startup developing next generation virotherapies targeted with nucleic acids. The pre-clinical biotech aims to... Read more »

  Editors9/25/20

• Monte Rosa Raises $96M for “Glue-Based” Protein Degrading Drugs

  Many drugs work by binding to a protein and blocking it. Technology for eliminating disease-causing proteins altogether remains experimental, but this approach has gained ground in the past year with hundreds of millions of dollars raised and compounds advanced into clinical... Read more »

  Frank Vinluan9/24/20

• And the 2020 National Xconomy Awards Winners Are…

  Congratulations to all the finalists and winners!

  This year we received over 600 nominations across 10 award categories. Each nomination was carefully reviewed and ranked by the Xconomy editorial staff yielding 40 finalists. All have made unique, game-changing contributions that improve... Read more »

  Editors9/24/20

• Libra Strikes a Balance With Approach to ALS and Other Neuro Disorders

  Amyotrophic lateral sclerosis (ALS) has no cure and few available treatments but the past decade has revealed new knowledge about the pathology of the disease. Libra Therapeutics is turning that research into potential therapies, and it now has $29 million to... Read more »

  Frank Vinluan9/23/20

• Tau-Targeting Alzheimer’s Drug from AC Immune, Roche Fails in Phase 2

  An Alzheimer’s disease drug from partners AC Immune and Roche has failed a mid-stage clinical trial, adding another compound to the list of experimental therapies that have fallen short of demonstrating that they can treat the neurodegenerative disorder.

  The drug, semorinemab,... Read more »

  Frank Vinluan9/23/20

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