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Courtesy of Sarepta


SAREPTA DUCHENNE GENE THERAPY WINS BROADER USE FROM FDA

The decision makes Elevidys available to Duchenne patients at least 4 years of
age, despite mixed trial results that have led to skepticism about its
effectiveness. Read more ➔


TOP STORIES


 1. TWICE-YEARLY SHOTS OF GILEAD HIV DRUG EFFECTIVE IN LARGE PREVENTION STUDY

 2. Obesity drugs
    
    
    OBESITY DRUG FROM ZEALAND SHOWS POTENTIAL IN EARLY TRIAL


 3. NEW DATA SHOWCASE PROMISE, GROWING PAINS OF CAR-T IN AUTOIMMUNE DISEASE


 4. ABORTION PILL RULING OFFERS MEASURE OF RELIEF FOR FDA, BIOTECH


 5. PFIZER SETBACK BRINGS QUESTIONS FOR DUCHENNE GENE THERAPY AHEAD OF SAREPTA
    DECISION


THE LATEST

 * Access now➔
   
   Trendline
   
   
   INSIDE THE MARKET OF EMERGING BIOTECHS
   
   New biotechs continue to emerge despite a challenging market environment that
   has forced venture firms to build their drug startups more cautiously.

 * Adeline Kon/BioPharma Blog
   Deep Dive // Emerging biotech
   
   
   BIOTECH IPOS ARE THE INDUSTRY’S LIFEBLOOD. TRACK HOW THEY’RE PERFORMING.
   
   Cancer drug developer OS Therapies, which withdrew its offering twice in the
   last month, aims to price what would be the 12th biotech IPO this year.
   
   Updated 14 hours ago
   Biotech

 * iStock / PRImageFactory
   
   Sponsored by Phreesia
   
   
   EARLY PATIENT ENGAGEMENT CAN IMPROVE MEDICATION ADHERENCE. HERE’S HOW.
   
   Research shows that 20% of patients have failed to fill a script in the past,
   and one-third aren’t confident managing their illness. Engaging patients as
   soon as a medicine is prescribed can help.
   
   Marketing
 * whitehoune via Getty Images
   
   
   FDA LIFTS HOLD ON PTC HUNTINGTON’S DISEASE TRIAL
   
   The agency has lifted a partial trial suspension based on one-year data
   showing PTC’s pill suppressed a key protein associated with the disorder.
   
   Biotech
 * Courtesy of Amazon
   
   
   AMAZON EXPANDS DRUG SUBSCRIPTION PROGRAM TO MEDICARE MEMBERS
   
   RxPass, which fills prescriptions for generic drugs, is now available to more
   than 50 million Medicare members after Amazon brought it into compliance with
   the insurance program’s regulatory standards.
   
   Marketing
 * Access now➔
   
   Trendline
   
   
   INSIDE THE WORLD OF CELL THERAPIES
   
   Six CAR-T cell therapies are now approved in the U.S., and their continued
   emergence has helped fueled further research into next-generation approaches.
   
   Access now➔
   
   Trendline
   
   
   INSIDE THE MARKET OF EMERGING BIOTECHS
   
   New biotechs continue to emerge despite a challenging market environment that
   has forced venture firms to build their drug startups more cautiously.

 * Kena Betancur via Getty Images
   
   
   MERCK WINS FDA OK FOR VACCINE RIVAL TO PFIZER’S PNEUMOCOCCAL SHOT
   
   The new vaccine, which Merck will sell as Capvaxive, will compete with
   Pfizer’s blockbuster Prevnar franchise.
   
   Pharma
 * Permission granted by Marea Therapeutics
   Emerging biotech
   
   
   LINGERING CHOLESTEROL CAN KEEP HEART RISK HIGH. MAREA THERAPEUTICS HAS $190M
   TO TARGET IT.
   
   With a drug licensed from Novartis, the new biotech startup aims to reduce
   the ‘remnant’ cholesterol it says existing medicines can’t address.
   
   Biotech
 * Adeline Kon/BioPharma Blog
   Deep Dive
   
   
   BIOTECH M&A IS ON THE UPSWING. TRACK THE LATEST DEALS HERE.
   
   Eleven private biotech companies have been acquired through May, putting 2024
   on pace to be a particularly strong year for startup M&A.
   
   Updated May 29, 2024
   Deals
 * Elizabeth Regan / Biopharma Blog
   
   
   INTRA-CELLULAR DEPRESSION DRUG SUCCEEDS IN SECOND LATE-STAGE STUDY
   
   The results position the company to unlock what’s believed to be a
   multibillion-dollar sales opportunity for Caplyta, which is already used to
   treat schizophrenia and bipolar disorder.
   
   Clinical Trials
 * Access now➔
   
   Trendline
   
   
   THE LATEST DEVELOPMENTS IN ONCOLOGY RESEARCH
   
   More than one quarter of the medcines cleared by the FDA’s main review office
   since 2015 have been cancer drugs, a tally that reflects the advent of cancer
   immunotherapy as well as continued progress in matching treatment to
   genetics.
   
   Access now➔
   
   Trendline
   
   
   INSIDE THE WORLD OF CELL THERAPIES
   
   Six CAR-T cell therapies are now approved in the U.S., and their continued
   emergence has helped fueled further research into next-generation approaches.

 * Permission granted by Kevin Trimmer/Ascidian Therapeutics
   
   
   ROCHE PARTNERS WITH RNA EDITING BIOTECH ASCIDIAN
   
   While the Swiss pharma recently pruned its neurology drug pipeline, it has
   shown interest in the possibilities of RNA-focused approaches like what
   Ascidian is exploring.
   
   Pharma
 * Daniel Tadevosyan via Getty Images
   News roundup
   
   
   SANOFI TAPS BELHARRA FOR IMMUNE DRUG RESEARCH; ASTRAZENECA’S NEW CANCER DRUG
   FALLS SHORT
   
   Belharra will use its chemoproteomics technology to identify immune drugs for
   Sanofi. Elsewhere, Regenxbio mapped a regulatory path and Taysha shared
   updated results for its Rett treatment.
   
   Pharma
 * Stock via Getty Images
   
   
   TAKEDA DRUG FOR RARE TYPES OF EPILEPSY MISSES GOAL IN LATE-STAGE TRIAL
   
   Called soticlestat, the drug had seemed promising in earlier studies for
   people with Dravet and Lennox-Gastaut syndrome, enough to persuade Takeda to
   take on full rights to the drug.
   
   Pharma
 * Adeline Kon / BioPharma Blog/BioPharma Blog
   Deep Dive // Patent thickets
   
   
   DRUG PATENTS PROTECT PHARMA PROFITS. TRACK WHEN THEY’LL EXPIRE HERE.
   
   Intellectual property is the foundation of the drug industry’s business
   model. This database will track key patent expiry dates for 30 top-selling
   medicines.
   
   Updated May 13, 2024
   Pharma
 * Maximusnd via Getty Images
   
   
   SYNCONA MELDS TWO GENE THERAPY BIOTECHS FOR BETTER SHOT AT NEW NERVOUS SYSTEM
   TREATMENTS
   
   The new company, Spur Therapeutics, is getting another $50 million from
   Syncona to support its broadened pipeline, which targets Parkinson’s disease
   as well as heart conditions.
   
   Biotech
 * Courtesy of AbbVie
   
   
   ABBVIE JOINS IN LATEST GASTROINTESTINAL DRUG CHASE
   
   Following Roche, Merck and others into a hot field, the Humira maker will pay
   $150 million to license a preclinical TL1A antibody for IBD.
   
   Biotech
 * Michael M. Santiago via Getty Images
   
   
   RADIOPHARMA DRUGMAKER TELIX PULLS US IPO PLANS
   
   The Australia-based company had proposed raising $202 million via an initial
   stock sale, but withdrew its filing, citing its shares’ recent price
   appreciation on Australia’s stock exchange.
   
   Biotech
 * Daniel Tadevosyan via Getty Images
   News roundup
   
   
   TAKEDA CIRCLES A LEUKEMIA DRUG; J.P. MORGAN MOVES INTO BIOTECH INVESTING
   
   The Japanese pharma paid $100 million to secure option rights to an Ascentage
   drug. Elsewhere, J.P. Morgan Private Capital closed its first fund and the
   FDA gave new COVID shot advice.
   
   Pharma
 * Permission granted by Versant Ventures
   Emerging biotech
   
   
   VERSANT DEBUTS BIOTECH WORKING ON ‘ANGER MANAGEMENT FOR THE IMMUNE SYSTEM’
   
   Investor enthusiasm for precision immunology medicines is providing a
   tailwind for Santa Ana Therapeutics, a new startup backed by Versant, GV and
   a16z, among others.
   
   Biotech
 * Anna Moneymaker via Getty Images
   
   
   SUPREME COURT PRESERVES ACCESS TO ABORTION PILL IN UNANIMOUS RULING
   
   The high court said the plaintiffs’ “desire to make a drug less available to
   others” did not give them standing to challenge the FDA’s expansion of
   mifepristone’s approval.
   
   Pharma
 * Joe Raedle/Getty Images via Getty Images
   
   
   MODERNA SAYS NEXT-GEN COVID SHOT EFFECTIVE IN STUDY
   
   Trial data suggest the shot — an important component of an upcoming
   combination inoculation — has proven at least as effective, and in some cases
   superior, to the company’s initial COVID vaccine.
   
   Biotech
 * George Clerk via Getty Images
   
   
   PFIZER GENE THERAPY FOR DUCHENNE FAILS TO MEET GOALS OF KEY TRIAL
   
   The negative results from the Phase 3 study, called Ciffreo, come a little
   more than a month after Pfizer said a patient died in another trial of the
   gene therapy.
   
   Clinical Trials
 * Pla2Na via Getty Images
   
   
   FORESITE, A BIOTECH VENTURE FIRM, RELOADS WITH $900M FUND
   
   Amid some optimism for biotech startups, the firm sees opportunities to fund
   companies “at all stages of the productive development life cycle,” said
   managing director Vik Bajaj.
   
   Biotech
 * Igor Kutyaev via Getty Images
   
   
   REGENXBIO CEO TO STEP DOWN AFTER 15 YEARS
   
   Kenneth Mills will become chair of the gene therapy developer’s board while
   Curran Simpson, the current chief operating officer, will take his place as
   company head.
   
   Biotech
 * Jeenah Moon via Getty Images
   Obesity drugs
   
   
   FLAGSHIP TAPS STARTUP TO HUNT FOR OBESITY DRUGS THAT MIGHT INTEREST PFIZER
   
   The venture firm will work with ProFound Therapeutics to “rapidly surface”
   protein drug candidates that Pfizer can choose to advance under a partnership
   it struck with Flagship last year.
   
   Biotech
 * Daniel Tadevosyan via Getty Images
   News roundup
   
   
   AVIDITY DRUG FOR MUSCULAR DYSTROPHY SHOWS PROMISE; SYNTIS TAKES NEW APPROACH
   TO WEIGHT LOSS
   
   Study results indicated Avidity’s medicine muted target genes. Elsewhere,
   Syntis revealed obesity drug plans and Nodthera chalked up more positive data
   for its NLRP3 inhibitor.
   
   Pharma

 * Image courtesy of Ultragenyx.
   
   
   ULTRAGENYX, MEREO DRUG REDUCES FRACTURES IN BONE DISORDER STUDY
   
   New data show the treatment’s effect on fractures and bone density held up
   over time, boosting the drug’s prospects ahead of a Phase 3 readout.
   
   Biotech
 * Love Employee via Getty Images
   
   
   ADCS ARE IN FOCUS. HERE’S WHERE ASTRAZENECA, ABBVIE HOPE TO TAKE THE FIELD
   NEXT.
   
   Newer components and drug combinations could expand use of the targeted
   cancer medicines, according to company executives.
   
   Pharma

More stories
Access now➔

Trendline


THE LATEST DEVELOPMENTS IN ONCOLOGY RESEARCH

More than one quarter of the medcines cleared by the FDA’s main review office
since 2015 have been cancer drugs, a tally that reflects the advent of cancer
immunotherapy as well as continued progress in matching treatment to genetics.


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MOST POPULAR

 1. Twice-yearly shots of Gilead HIV drug effective in large prevention study
 2. Sarepta Duchenne gene therapy wins broader use from FDA
 3. New data showcase promise, growing pains of CAR-T in autoimmune disease
 4. Lingering cholesterol can keep heart risk high. Marea Therapeutics has $190M
    to target it.


LIBRARY RESOURCES

 * Playbook
   How to Use Data to Upgrade Your Drug Commercialization Strategy Custom
   content for McKesson Compile
 * Podcast
   Looking Ahead: Pipeline Development Custom content for BioLineRx
 * Trendline
   Inside the booming weight loss drug market Supported by Quest Diagnostics

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COMPANY ANNOUNCEMENTS

 * New TrialAssure LINK® AI 2.0 Medical Writing Technology Debuts to the
   Pharmaceutical Industry … From TrialAssure
 * Precis Engineering + Architecture Hires Jaime C. Leite, CEM, LEED AP BD+C, as
   Project Executive From Precis Engineering + Architecture
 * Octane Medical acquires B. Braun’s global orthobiologics business From Octane
   Medical Group
 * Industry Update: Dr. Reddy’s Growth Trajectory: Breaking Down the Pharma
   Giant’s Record Revenu… From PESG Research

View all | Post a press release


WHAT WE’RE READING

 * The Washington Post Rare gene mutation helps people resist Alzheimer’s
   disease
 * ApexOnco Merck seeks the next Keytruda
 * Reuters Lilly files more lawsuits to curb sales of counterfeit Mounjaro

View all


INDUSTRY INTEL

 * Developing an Array of Diverse Vaccine Platforms Webinar - on demand •
   Provided by BioPharma Blog’s studioID; Sponsored content by Novavax in
   partnership with studioID
 * Adaptive Trial Design for Phase 1 Dose-Finding Studies Webinar - on demand •
   Provided by Certara
 * _eBook: Advancing 3D Culture Imaging_ eBook • Provided by Leica Microsystems

Access now➔

Trendline


INSIDE THE BOOMING WEIGHT LOSS DRUG MARKET

GLP-1 agonists like Ozempic and Wegovy can drive significant weight loss and, at
least in Wegovy’s case, protect the heart. Their adoption is changing how
doctors treat obesity. 

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