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     * SANOFI, PFIZER & BRISTOL DRUGS AMONG THE 12 APPROVALS TO LOOK OUT FOR IN
       Q4
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     * FDA PANEL VOTE WEIGHS IN FAVOR OF ALKERMES PSYCH DRUG, WITH CAVEATS
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     * “OPIOID STACKING” CONCERNS LEAD FDA TO REJECT AVENUE THERAPEUTICS DRUG
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     * DESPITE PHASE 2 FAILURE, GOSSAMER BIO SEES A PATH FOR DRUG IN ASTHMA
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TOP STORIES




 * VERTEX STOPS TEST OF RARE DISEASE DRUG, DIMMING PIPELINE PROSPECTS


 * ROCHE ENLISTS DYNO TO BRING AI TO NEXT-GENERATION LIVER, CNS GENE THERAPIES


 * SQZ BIOTECH LINES UP AN IPO ON THE NYSE TO FUND CELL THERAPY R&D


 * FDA PANEL VOTE WEIGHS IN FAVOR OF ALKERMES PSYCH DRUG, WITH CAVEATS


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

   Load More News ›


 * 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

   Load More News ›


 * 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

   Read More Posts ›


XCONOMIST FORUMEXPERT INSIGHT AND OPINION


 * CLINICAL TRIAL DIVERSITY ISN’T JUST A MORAL ISSUE–IT’S A SCIENTIFIC
   IMPERATIVE
   
   
   
   LIZ BEATTY


 * CREATING CONSISTENT VALUE IN BIOTECH WITHOUT DILUTING STAKEHOLDERS
   
   
   
   ALEXIS PEYROLES


 * LAX APPROVAL REQUIREMENTS YIELD BLOCKBUSTERS THAT DON’T WORK
   
   
   
   ANDY SMITH


 * DIGITAL HEALTH SURVIVORS & INNOVATIVE INCUMBENTS MUST TEAM UP FOR TRUE
   DISRUPTION
   
   
   
   BRYONY WINN

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