March, 2023

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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

Bio Pharma Dive

Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells

Protein 353
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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential.

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QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ).

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Moderna opts for Oxfordshire in quest for innovation

Pharma Times

Vaccines developed at the facility will cover a wide range of respiratory diseases

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.

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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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CRISPR/ViaCyte and Genprex Vie for First Diabetes Gene Therapy

BioSpace

CRISPR/ViaCyte and Genprex Vie for First Diabetes Gene Therapy 3/13/2023

More Trending

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Tapping into digital therapeutics to improve neurological outcomes

Pharmaceutical Technology

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market.

Packaging 278
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HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval

FDA Law Blog

Hyman, Phelps & McNamara, P.C.’s s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy.

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Owlstone Medical collaborates with Bicycle Therapeutics

Pharma Times

Duo team up for the development of antigen-targeted probes for early cancer detection

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Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD

Fierce Pharma

Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD kdunleavy Thu, 03/23/2023 - 01:37

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2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

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Embattled CytoDyn Sets New Course Toward NASH, Tough Tumors

BioSpace

Embattled CytoDyn Sets New Course Toward NASH, Tough Tumors 3/15/2023

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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more

Protein 360
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‘Right shoring’ API production in Europe

Pharmaceutical Technology

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. It was a money-saving strategy that was paying off until Covid-19 hit.

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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

FDA Law Blog

By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ).

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

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PBD Biotech reveals vital update to TB test

Pharma Times

Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test

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Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

Fierce Pharma

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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The Rise, Fall and Future of Novavax

BioSpace

The Rise, Fall and Future of Novavax 3/21/2023

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Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

Bio Pharma Dive

The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo

Trials 308
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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

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Pharmanovia signs licence deal for Aeterna Zentaris’ Ghryvelin

Pharmaceutical Technology

Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health.

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JOIN HP&M FOR A WEBINAR: “The ‘End’ of the COVID-19 Emergency: The Ryan Haight Act, Telemedicine, and Next Steps?” on Thursday, March 23, 2023 at 12 Noon EST

FDA Law Blog

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements.

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Recommendation from NICE for PTC Therapeutics gene therapy

Pharma Times

Eladocagene exuparvovec is for children with ultra-rare genetic disorder in final draft guidance

Genetics 115
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After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court

Fierce Pharma

After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court kdunleavy Wed, 03/22/2023 - 14:39

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Advancing ‘Smart Pharma’ Capabilities in 2023 and Beyond

Pharmaceutical Commerce

Q&A explores new opportunities to strengthen supply chain resilience—and build on the lessons learned.

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With focus on fibrosis, startup Mediar draws big pharma backing

Bio Pharma Dive

Novartis joined venture investor Sofinnova in leading an $85 million investment in the startup that also involved Pfizer, Eli Lilly and Bristol Myers Squibb

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Risk sharing agreements soar as market access risk increases

Pharmaceutical Technology

Over the last twenty years, there has been a major rise in risk sharing agreements in the pharmaceutical space, said Alex Watt, GlobalData’s principal research analyst, at a recent webinar on the same topic.

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Barroom (Promotional) Brawl

FDA Law Blog

By Charles D. Snow — As Benjamin Franklin once ( apocryphally ) stated: “Beer is proof that God loves us and wants us to be happy.” And what comes with such a heaven-sent, nourishing beverage? Mainly hangovers and beer bellies, but also fierce marketplace competition and gamesmanship.

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Immutep reveals initiation of pivotal Efti study

Pharma Times

The clinical trial also involves paclitaxel in the treatment of metastatic breast cancer

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Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul

Fierce Pharma

Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul fkansteiner Wed, 03/01/2023 - 08:40

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Samsung Biologics to start construction of Plant 5

BioPharma Reporter

Samsung Biologics will begin construction of Plant 5 within the first half of this year: marking the first facility for its second Bio Campus. Upstream Processing

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SVB’s failure was contained. Its effects on biotech could still linger.

Bio Pharma Dive

“A generation of founders is now scarred,” one biotech CEO said, as small drugmakers grapple with the longer-lasting effects of SVB’s stunning collapse

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Talem and Libera Bio partner for discovery of AI-driven antibodies

Pharmaceutical Technology

Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio.

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Moderna Eyes Accelerated Approval for mRNA Cancer Vaccine

BioSpace

Moderna Eyes Accelerated Approval for mRNA Cancer Vaccine 3/7/2023

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ABPI responds to rebooted MHRA clinical trials framework

Pharma Times

Measures include a requirement to publicly register studies and share results among research participants