Bio Pharma Dive
MARCH 22, 2023
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
Pharmaceutical Technology
MARCH 6, 2023
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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FDA Law Blog
MARCH 6, 2023
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 ).
Pharma Times
MARCH 6, 2023
Vaccines developed at the facility will cover a wide range of respiratory diseases
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.
Fierce Pharma
MARCH 22, 2023
AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17
BioSpace
MARCH 12, 2023
CRISPR/ViaCyte and Genprex Vie for First Diabetes Gene Therapy 3/13/2023
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MARCH 17, 2023
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.
FDA Law Blog
MARCH 19, 2023
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.
Pharma Times
MARCH 15, 2023
Duo team up for the development of antigen-targeted probes for early cancer detection
Fierce Pharma
MARCH 22, 2023
Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD kdunleavy Thu, 03/23/2023 - 01:37
Advertiser: FourKites
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.
BioSpace
MARCH 14, 2023
Embattled CytoDyn Sets New Course Toward NASH, Tough Tumors 3/15/2023
Bio Pharma Dive
MARCH 7, 2023
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
Pharmaceutical Technology
MARCH 22, 2023
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.
FDA Law Blog
MARCH 13, 2023
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 ).
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.
Pharma Times
MARCH 15, 2023
Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test
Fierce Pharma
MARCH 10, 2023
Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22
BioSpace
MARCH 20, 2023
The Rise, Fall and Future of Novavax 3/21/2023
Bio Pharma Dive
MARCH 17, 2023
The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo
Advertiser: Aggregage
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.
Pharmaceutical Technology
MARCH 17, 2023
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.
FDA Law Blog
MARCH 12, 2023
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.
Pharma Times
MARCH 23, 2023
Eladocagene exuparvovec is for children with ultra-rare genetic disorder in final draft guidance
Fierce Pharma
MARCH 22, 2023
After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court kdunleavy Wed, 03/22/2023 - 14:39
Pharmaceutical Commerce
MARCH 13, 2023
Q&A explores new opportunities to strengthen supply chain resilience—and build on the lessons learned.
Bio Pharma Dive
MARCH 15, 2023
Novartis joined venture investor Sofinnova in leading an $85 million investment in the startup that also involved Pfizer, Eli Lilly and Bristol Myers Squibb
Pharmaceutical Technology
MARCH 17, 2023
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.
FDA Law Blog
MARCH 2, 2023
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.
Pharma Times
MARCH 14, 2023
The clinical trial also involves paclitaxel in the treatment of metastatic breast cancer
Fierce Pharma
MARCH 1, 2023
Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul fkansteiner Wed, 03/01/2023 - 08:40
BioPharma Reporter
MARCH 20, 2023
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
Bio Pharma Dive
MARCH 14, 2023
“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
Pharmaceutical Technology
MARCH 16, 2023
Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio.
BioSpace
MARCH 7, 2023
Moderna Eyes Accelerated Approval for mRNA Cancer Vaccine 3/7/2023
Pharma Times
MARCH 22, 2023
Measures include a requirement to publicly register studies and share results among research participants
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