Drug Discovery Digest

Roche strikes Orionis deal to develop ‘molecular glues’ for cancer

BioPharma Drive: Drug Pricing

MAY 21, 2025

The Swiss pharma has inked several collaborations in this field, suggesting it sees the approach as promising to rid the body of destructive proteins that are hard to target by other means.

FDA OKs first blood test to aid Alzheimer’s diagnosis

BioPharma Drive: Drug Pricing

MAY 19, 2025

The FDA cleared the test for early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

FDA

FDA Disease

Regeneron wins bid to buy 23andMe out of bankruptcy

BioPharma Drive: Drug Pricing

MAY 19, 2025

The biotech, which has for years invested in genetics research, plans to acquire "substantially all" of testing firm 23andMe's assets for $256 million.

Research

Bridging the data gaps that impact retail and specialty-lite success

BioPharma Drive: Drug Pricing

MAY 19, 2025

Learn how to leverage predictive analytics and measure top KPIs to maximize patient outcomes, provider engagement and brand performance on this webinar from PHIL and Syneos Health.

From insight to impact: How eCOAs strengthen trial data quality

BioPharma Drive: Drug Pricing

MAY 19, 2025

Timely, high-integrity insights for sponsors that reduce risk and move trials forward.

Trials

How regulatory convergence is raising the bar for sterile drug safety—and how West leads the way

BioPharma Drive: Drug Pricing

MAY 19, 2025

Global regulators continue to raise the bar on sterile drug manufacturing—and West is responding.

Regulations

Regulations Drugs

Bluebird extends deal deadline; Affimed files for insolvency

BioPharma Drive: Drug Pricing

MAY 14, 2025

Shareholders in Bluebird now have a choice of two offers from would-be acquirers Carlyle and SK Capital. Elsewhere, Cytokinetics shared more aficamten data and BridgeBio started a new kind of Attruby trial.

Trials

Novo to work with Septerna in hunt for oral obesity drugs

BioPharma Drive: Drug Pricing

MAY 14, 2025

The research collaboration, under which Septerna will receive more than $200 million in upfront and near-term fees, is the latest deal Novo has struck to expand its obesity pipeline.

Drugs

Drugs Research

GSK to buy liver disease drug for $1.2B

BioPharma Drive: Drug Pricing

MAY 14, 2025

The new acquisition from Boston Pharmaceuticals adds to a wave of dealmaking undertaken by GSK to build its liver disease franchise.

Disease

Disease Pharmaceuticals Drugs

AI specialist Recursion trims pipeline in latest shakeup

BioPharma Drive: Drug Pricing

MAY 5, 2025

The cuts to three advanced drug programs were “inevitable” given the company’s “unsustainable cash burn,” one analyst wrote in a note to investors.

Drugs

PTC stock slides on new data for Huntington’s drug

BioPharma Drive: Drug Pricing

MAY 5, 2025

While updated study results confirmed the drug lowers a target protein, the therapy's effect on clinical outcomes was less clear-cut.

Drugs

Drugs Therapies

Deerfield secures more than $600M for its next biotech venture fund

BioPharma Drive: Drug Pricing

MAY 5, 2025

The firm, a prolific backer of drug startups, will use the cash to back companies working on therapeutics, medical devices and healthcare services.

Drugs

CVS strikes Wegovy deal with Novo Nordisk

BioPharma Drive: Drug Pricing

MAY 1, 2025

The deal could expand access to its in-demand obesity drug at the expense of Eli Lilly, whose shares fell by double digits on Thursday.

Drugs

AstraZeneca quietly exits neuroscience

BioPharma Drive: Drug Pricing

MAY 1, 2025

The company removed experimental drugs for Alzheimer’s, migraine and pain from its pipeline to focus more resources on “core therapeutic areas” and “high value” programs.

Drugs

Siren, a gene therapy startup, tests unconventional alternative to venture funding

BioPharma Drive: Drug Pricing

MAY 1, 2025

Siren Biotechnology is trying to raise $5 million via the type of crowdfunding round that’s rarely used by young drugmakers.

Therapies

FDA misses approval deadline for a biotech’s rare disease drug

BioPharma Drive: Drug Pricing

APRIL 29, 2025

The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.

FDA

FDA Disease Drugs

Top Republican calls for 340B reform in long-awaited investigation

BioPharma Drive: Drug Pricing

APRIL 28, 2025

Sen. Bill Cassidy’s report calls on Congress to improve the transparency of the drug discount program in a move praised by pharmaceutical companies and criticized by hospitals.

Pharmaceutical Companies

Pharmaceutical Companies Hospitals Pharmaceuticals Drugs

How integrated real-world data helps identify and improve outcomes for rare disease patients

BioPharma Drive: Drug Pricing

APRIL 28, 2025

Pharmaceutical companies are turning to integrated RWD approaches to overcome challenges in rare disease research.

Disease

Disease Pharmaceutical Companies Pharmaceuticals Research

Biohaven stock slides on withdrawal of European marketing application

BioPharma Drive: Drug Pricing

APRIL 25, 2025

The drug, being developed for a rare genetic disorder and currently under review in the U.S., is seen by some investors as critical to Biohaven’s future.

Marketing

Marketing Drugs

Caribou, in reversal, scraps autoimmune cell therapy and cuts staff

BioPharma Drive: Drug Pricing

APRIL 25, 2025

The CRISPR company is laying off about a third of its employees and stopping work on an experimental lupus treatment in a bid to focus resources on a pair of cancer cell therapies.

Therapies

Therapies Treatment

Merck takes $200M tariff hit, trimming its gross profits

BioPharma Drive: Drug Pricing

APRIL 24, 2025

The drugmaker absorbed additional tariff-related costs in the first quarter, but has taken steps to lower the financial impact it’ll have for the rest of the year and beyond.

Etiome, a new Flagship startup, looks to catch disease before it strikes

BioPharma Drive: Drug Pricing

APRIL 24, 2025

The biotech is using AI and a trove of health data to better understand why certain conditions progress and intervene beforehand with a targeted medication.

Disease

Roche, answering tariff threat, pledges $50B to US drug production

BioPharma Drive: Drug Pricing

APRIL 22, 2025

The big pharma joined several of its peers in committing to invest billions of dollars in new and expanded manufacturing facilities in the U.S.

Production

Production Drugs

Novo says it’s submitted obesity pill for FDA approval

BioPharma Drive: Drug Pricing

APRIL 21, 2025

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.

FDA Approval

FDA Approval FDA Regulations Drugs

FDA cuts outlined in draft HHS budget

BioPharma Drive: Drug Pricing

APRIL 18, 2025

The leaked budget draft, if approved by Congress, would reduce the FDA’s budget authority, indicating more disruption could be in store for an agency already shaken by large-scale layoffs.

FDA

Bluebird says Ayrmid missed deadline for rival takeover bid

BioPharma Drive: Drug Pricing

APRIL 16, 2025

The company’s board reiterated its recommendation to instead pursue an offer from SK Capital and Carlyle that’s worth about $29 million upfront.

CDC panel mulls changes to COVID shot recommendations

BioPharma Drive: Drug Pricing

APRIL 16, 2025

The advisory committee, which met Tuesday for the first time since Robert F. Kennedy Jr. was sworn in as health secretary, also discussed the Texas measles outbreak.

New research kindles excitement around stem cell therapies for Parkinson’s

BioPharma Drive: Drug Pricing

APRIL 16, 2025

Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain, but also show promising — albeit unproven — signs of efficacy.

Therapies

Therapies Research Production

Startup Glycomine raises $115M to push rare disease drug deeper into testing

BioPharma Drive: Drug Pricing

APRIL 16, 2025

The biotech is developing an experimental drug for the most common of a family of disorders all caused by errors in glycosylation.

Disease

Disease Drugs

US launches probe that could set stage for pharma tariffs

BioPharma Drive: Drug Pricing

APRIL 14, 2025

The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.

Pharmaceuticals

FDA plans to phase out animal testing for some drugs

BioPharma Drive: Drug Pricing

APRIL 11, 2025

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.

Animal Testing

Animal Testing FDA Drugs

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

BioPharma Drive: Drug Pricing

APRIL 10, 2025

Amid a funding drought for startups, the company is looking for a deal that can advance its liver cancer drug.

Trials

Trials Drugs

Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

BioPharma Drive: Drug Pricing

APRIL 10, 2025

Experts say the layoffs are already causing issues in drug development — and things may get far worse without critical institutional knowledge at the FDA.

FDA

FDA Drug Development Drugs

US risks losing biotech edge to China, report warns

BioPharma Drive: Drug Pricing

APRIL 8, 2025

“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.

RFK Jr. won’t appear before Senate panel this week

BioPharma Drive: Drug Pricing

APRIL 7, 2025

HELP committee chair Bill Cassidy, R-La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A hearing could still take place later.

HHS begins layoffs in chaotic fashion

BioPharma Drive: Drug Pricing

APRIL 1, 2025

Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as cuts hit CDER.

FDA

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

BioPharma Drive: Drug Pricing

MARCH 31, 2025

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

Therapies

Therapies FDA Regulations

FDA official’s ouster sends shares of vaccine makers sliding

BioPharma Drive: Drug Pricing

MARCH 31, 2025

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

Vaccine

Vaccine FDA

How discoverable, comparable and explorable is your data?

BioPharma Drive: Drug Pricing

MARCH 31, 2025

Accelerate biomarker research with high-quality, expert-curated data to drive precision medicine.

Research

Peter Marks, FDA’s top vaccine official, resigns

BioPharma Drive: Drug Pricing

MARCH 29, 2025

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.

Vaccine

FDA approves first-of-its-kind RNA drug for hemophilia

BioPharma Drive: Drug Pricing

MARCH 28, 2025

The Sanofi drug, known as fitusiran and now Qfitlia, was approved on Friday for a broad group of people with the rare bleeding disorder.

FDA Approval

FDA Approval RNA FDA Drugs

FDA broadens use of Novartis’ radiopharma drug Pluvicto

BioPharma Drive: Drug Pricing

MARCH 28, 2025

Pluvicto can now be used before chemotherapy to treat a kind of metastatic prostate cancer, tripling the number of patients who are eligible for treatment.

FDA

FDA Treatment Drugs

Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen

BioPharma Drive: Drug Pricing

MARCH 28, 2025

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal the verdict, a strategy successfully employed by Eisai.

Regulations

Regulations Marketing

HHS to cut 10,000 staff in major restructuring under RFK Jr.

BioPharma Drive: Drug Pricing

MARCH 27, 2025

The FDA will lose about 3,500 employees under the plans, although HHS said drug, medical device and food reviewers will not be affected.

FDA

FDA Drugs

BioPharma Drive: Drug Pricing

Roche strikes Orionis deal to develop ‘molecular glues’ for cancer

FDA OKs first blood test to aid Alzheimer’s diagnosis

Trending Sources

Regeneron wins bid to buy 23andMe out of bankruptcy

Bridging the data gaps that impact retail and specialty-lite success

From insight to impact: How eCOAs strengthen trial data quality

How regulatory convergence is raising the bar for sterile drug safety—and how West leads the way

Bluebird extends deal deadline; Affimed files for insolvency

Novo to work with Septerna in hunt for oral obesity drugs

GSK to buy liver disease drug for $1.2B

AI specialist Recursion trims pipeline in latest shakeup

PTC stock slides on new data for Huntington’s drug

Deerfield secures more than $600M for its next biotech venture fund

CVS strikes Wegovy deal with Novo Nordisk

AstraZeneca quietly exits neuroscience

Siren, a gene therapy startup, tests unconventional alternative to venture funding

FDA misses approval deadline for a biotech’s rare disease drug

Top Republican calls for 340B reform in long-awaited investigation

How integrated real-world data helps identify and improve outcomes for rare disease patients

Biohaven stock slides on withdrawal of European marketing application

Caribou, in reversal, scraps autoimmune cell therapy and cuts staff

Merck takes $200M tariff hit, trimming its gross profits

Etiome, a new Flagship startup, looks to catch disease before it strikes

Roche, answering tariff threat, pledges $50B to US drug production

Novo says it’s submitted obesity pill for FDA approval

FDA cuts outlined in draft HHS budget

Bluebird says Ayrmid missed deadline for rival takeover bid

CDC panel mulls changes to COVID shot recommendations

New research kindles excitement around stem cell therapies for Parkinson’s

Startup Glycomine raises $115M to push rare disease drug deeper into testing

US launches probe that could set stage for pharma tariffs

FDA plans to phase out animal testing for some drugs

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

US risks losing biotech edge to China, report warns

RFK Jr. won’t appear before Senate panel this week

HHS begins layoffs in chaotic fashion

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

FDA official’s ouster sends shares of vaccine makers sliding

How discoverable, comparable and explorable is your data?

Peter Marks, FDA’s top vaccine official, resigns

FDA approves first-of-its-kind RNA drug for hemophilia

FDA broadens use of Novartis’ radiopharma drug Pluvicto

Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen

HHS to cut 10,000 staff in major restructuring under RFK Jr.

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