CMS lays out plans for negotiating drug prices
Bio Pharma Dive
MARCH 16, 2023
The guidance fills in details for one of the central pharmaceutical provisions of the Inflation Reduction Act, signaling how the agency will use its new authority
Thu.Mar 16, 2023
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Talem and Libera Bio partner for discovery of AI-driven antibodies
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.
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Esperion in dispute with Daiichi over drug milestone payment
Bio Pharma Dive
MARCH 16, 2023
The companies disagree over what qualifies for a payment of up to $300 million that’s associated with inclusion of heart data on the cholesterol drug’s label
Legal challenges put off label use of gender affirming care drugs in jeopardy
Pharmaceutical Technology
MARCH 16, 2023
Earlier this week, the Florida Senate advanced a bill to restrict gender-affirming care for transgender minors. The bill is one of many that are currently being discussed in different states.
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.
NICE approves funding for Novartis gene therapy
Pharma Times
MARCH 16, 2023
Funding is for onasemnogene abeparvovec and concerns babies with spinal muscular atrophy
Which biotechs need to find a new bank after the collapse of Silicon Valley Bank?
Pharmaceutical Technology
MARCH 16, 2023
Silicon Valley Bank (SVB), the 16th largest bank in the US, collapsed on Friday 10 March. Its operations were seized by the Federal Deposit Insurance Corporation after a nearly two-day bank run that resulted in approximately $175bn of customer deposits being put at risk.
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UCB enters drug discovery collaboration with Aitia
Pharmaceutical Technology
MARCH 16, 2023
Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder.
Novo Nordisk hit with two-year suspension from UK pharma group after online marketing breaches
Fierce Pharma
MARCH 16, 2023
Novo Nordisk hit with two-year suspension from UK pharma group after online marketing breaches fkansteiner Thu, 03/16/2023 - 09:00
UK MHRA grants marketing authorisation for argenx’s gMG therapy
Pharmaceutical Technology
MARCH 16, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for argenx’s Vyvgart (efgartigimod alfa-fcab) to treat generalised myasthenia gravis (gMG).
Discovery programme?launched by Cystic Fibrosis Syndicate
Pharma Times
MARCH 16, 2023
Aim for participants will be to quickly new antimicrobial therapies to treat chronic respiratory infections
2022 Research: The Rapid Rise of Ocean Freight Visibility
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.
Intergalactic plans to progress non-viral gene therapy program into the clinic
BioPharma Reporter
MARCH 16, 2023
Intergalactic Therapeutics, a startup focused on non-viral gene therapy, reports positive preclinical results for its lead program, IG-002, addressing all forms of ABCA4-related retinopathies. Bio Developments
Pfizer's Paxlovid gets thumbs-up for full approval from FDA advisory committee
Fierce Pharma
MARCH 16, 2023
Pfizer's Paxlovid gets thumbs-up for full approval from FDA advisory committee kdunleavy Thu, 03/16/2023 - 16:46
Amgen Cuts 450 Jobs in Second Round of Layoffs This Year
BioSpace
MARCH 16, 2023
Amgen Cuts 450 Jobs in Second Round of Layoffs This Year 3/17/2023
AstraZeneca employees fight layoffs in India as drugmaker shifts 'strategic priorities'
Fierce Pharma
MARCH 16, 2023
AstraZeneca employees fight layoffs in India as drugmaker shifts 'strategic priorities' aliu Thu, 03/16/2023 - 09:54
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.
FDA Reverses Course; Will Hold Adcomm for Sarepta’s DMD Gene Therapy
BioSpace
MARCH 16, 2023
FDA Reverses Course; Will Hold Adcomm for Sarepta’s DMD Gene Therapy 3/17/2023
Esperion and Daiichi Sankyo bump heads on Nexletol milestone payments
Fierce Pharma
MARCH 16, 2023
Esperion and Daiichi Sankyo bump heads on Nexletol milestone payments zbecker Thu, 03/16/2023 - 11:46
Esperion-Daiichi Sankyo Partnership Saga Continues with Payment Spat
BioSpace
MARCH 16, 2023
Esperion-Daiichi Sankyo Partnership Saga Continues with Payment Spat 3/17/2023
Inclusive Marketing: Having the Tools, People, and Process to Shape the Work
Intouch Solutions
MARCH 16, 2023
Inclusive marketing is a mindful approach to ensure that messaging, products, processes, and people enable underrepresented groups to fully experience and connect with a brand.
Mandatory COVID Vaccination Policy Template
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.
Pfizer and Astellas Seek Expanded Label for Expensive Prostate Cancer Drug
BioSpace
MARCH 16, 2023
Pfizer and Astellas Seek Expanded Label for Expensive Prostate Cancer Drug 3/17/2023
mRNA Therapeutics and mRNA Vaccines Industry: Current Scenario and Future Trends
Roots Analysis
MARCH 16, 2023
Messenger ribonucleic acid (mRNA) is a single-stranded molecule that is complementary to a gene’s DNA.
New patent expiration for Novartis drug PATANASE
Drug Patent Watch
MARCH 16, 2023
Annual Drug Patent Expirations for PATANASE Patanase is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There are two patents protecting… The post New patent expiration for Novartis drug PATANASE appeared first on DrugPatentWatch - Make Better Decisions.
HDA’s 2023 Distribution Management Conference Dives into DSCSA Specifics and More
Pharmaceutical Commerce
MARCH 16, 2023
Event—taking place in Indianapolis—places supply chain education at the forefront.
New patent expiration for Helsinn Hlthcare drug AKYNZEO
Drug Patent Watch
MARCH 16, 2023
Annual Drug Patent Expirations for AKYNZEO Akynzeo is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier.
It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2
FDA Law Blog
MARCH 16, 2023
By Richard A. Lewis, Senior Regulatory Device & Biologics Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2.
New patent for Vertex Pharms drug TRIKAFTA (COPACKAGED)
Drug Patent Watch
MARCH 16, 2023
Annual Drug Patent Expirations for TRIKAFTA+%28COPACKAGED%29 Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier.
'The Top Line': What the Silicon Valley Bank failure means for global markets and biotech, plus this week's headlines
Fierce Pharma
MARCH 16, 2023
The Top Line': What the Silicon Valley Bank failure means for global markets and biotech, plus this week's headlines tcarey Thu, 03/16/2023 - 14:51
Which pharmaceutical companies have the most drug patents in Peru?
Drug Patent Watch
MARCH 16, 2023
This chart shows the pharmaceutical companies with the most patents in Peru. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Peru?
Fierce Pharma Asia—Sun's price-fixing settlement; Eisai's coverage win; AstraZeneca's India layoffs
Fierce Pharma
MARCH 16, 2023
Fierce Pharma Asia—Sun's price-fixing settlement; Eisai's coverage win; AstraZeneca's India layoffs aliu Thu, 03/16/2023 - 14:52
Embracing the Future: The Benefits of Digitization in Pharmacovigilance
Cloudbyz
MARCH 16, 2023
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Genixus adds manufacturing facility for syringe production
Outsourcing Pharma
MARCH 16, 2023
The company will build out a manufacturing, warehousing, and distribution center in the US to expand capacity for syringes. Drug Delivery
MHRA gets £10m boost from UK government
BioPharma Reporter
MARCH 16, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) will receive Â10m ($12m) in extra government funding over the next two years: targeted at helping the agency adapt post-Brexit and accelerating routes for bringing new medicines onto the market. Markets & Regulations
Noema Pharma raises $112M in Series B financing for nervous system disorders
Outsourcing Pharma
MARCH 16, 2023
Oversubscribed, series B financing for Noema Pharmaâs clinical stage assets has been successfully closed raising $112 million from new and existing investors. Clinical Development
Genuv and Celltrion partner on antibody discovery work
BioPharma Reporter
MARCH 16, 2023
South Korean players, Celltrion and Genuv, are teaming up on the discovery and development of therapeutic antibodies using Genuv's mouse platform. Markets & Regulations
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