Pharmaceutical Technology
FEBRUARY 6, 2023
Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis.
Bio Pharma Dive
FEBRUARY 10, 2023
The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine
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Pharmaceutical Commerce
FEBRUARY 9, 2023
As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.
FDA Law Blog
FEBRUARY 7, 2023
By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market.
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.
Pharmaceutical Technology
FEBRUARY 10, 2023
4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).
Bio Pharma Dive
FEBRUARY 7, 2023
The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
FEBRUARY 7, 2023
Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics fkansteiner Tue, 02/07/2023 - 10:08
Pharmaceutical Technology
FEBRUARY 10, 2023
On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.
Bio Pharma Dive
FEBRUARY 6, 2023
In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient
Pharma Times
FEBRUARY 10, 2023
Study involves the treatment of adults with moderate-to-severe chronic hand eczema
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.
The Pharma Data
FEBRUARY 7, 2023
First and only heart failure therapy with proven mortality benefit across the full ejection fraction range Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
Pharmaceutical Technology
FEBRUARY 8, 2023
On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.
Bio Pharma Dive
FEBRUARY 7, 2023
The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world
Pharma Times
FEBRUARY 10, 2023
Collaboration has created method for heart failure patients to receive at-home treatment
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.
Fierce Pharma
FEBRUARY 8, 2023
BREAKING: Bayer taps Roche vet Anderson as its next CEO, pushing out Baumann esagonowsky Wed, 02/08/2023 - 11:28
Pharmaceutical Technology
FEBRUARY 5, 2023
The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.
Bio Pharma Dive
FEBRUARY 6, 2023
Naoki Okamura, currently Astellas’ chief strategy officer, will replace current CEO Kenji Yasukawa as the company attempts to “further accelerate growth &rdquo
Pharma Times
FEBRUARY 8, 2023
The pathway is a programme designed to develop pharmacists’ knowledge of mental health among patients
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.
Fierce Pharma
FEBRUARY 8, 2023
Novartis, Bayer marshal relief for Turkey and Syria following devastating earthquake fkansteiner Wed, 02/08/2023 - 09:56
Pharmaceutical Technology
FEBRUARY 10, 2023
AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on an operational basis. The company reported an increase of 1.6% on a reported basis in global net revenues to $15.121bn for the fourth quarter (Q4) of 2022.
Bio Pharma Dive
FEBRUARY 10, 2023
The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors
Pharma Times
FEBRUARY 7, 2023
Milestone therapy concerns the treatment of patients with symptomatic chronic heart failure
JAMA Internal Medicine
FEBRUARY 5, 2023
This cross-sectional study examines the death rates among active and nonactive physicians aged 45 to 84 years
Pharmaceutical Technology
FEBRUARY 7, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]).
Bio Pharma Dive
FEBRUARY 10, 2023
CMS laid out how it plans to implement a key provision of the Inflation Reduction Act, which requires drugmakers to pay rebates on price hikes within Medicare that are greater than inflation
Pharma Times
FEBRUARY 6, 2023
Alvotech will be responsible for supply and Advanz will oversee commercialisation of biosimilar
Fierce Pharma
FEBRUARY 7, 2023
AstraZeneca's Forxiga nabs expanded heart failure approval in Europe zbecker Tue, 02/07/2023 - 14:24
Pharmaceutical Technology
FEBRUARY 9, 2023
Teva Pharmaceutical Industries has reported $3.9bn revenue in the fourth quarter (Q4) of 2022, representing a 5% decline in US dollars or a 1% increase in local currency terms, from $4.1bn in the same quarter of the previous year.
Bio Pharma Dive
FEBRUARY 8, 2023
The company has begun enrolling patients in one of the largest Phase 3 programs in its history, a pair of trials that will test an anticoagulant it believes can be a future blockbuster
Pharma Times
FEBRUARY 7, 2023
Financing will allow company’s development of DNA synthesis chip technology to commercial scale
Drug Patent Watch
FEBRUARY 9, 2023
Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions. Patent Added
Pharmaceutical Technology
FEBRUARY 9, 2023
ReviR Therapeutics has signed a research collaboration and option-to-license agreement with Asieris Pharmaceuticals to discover new oncology therapeutics.
Bio Pharma Dive
FEBRUARY 9, 2023
Mineralys, which is developing a hypertension drug, followed closely behind Structure Therapeutics in pricing an IPO, suggesting an opening investment window
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