Trending Articles

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Karuna, hoping to find new brain drugs, buys up a shuttering biotech’s pipeline

Bio Pharma Dive

Though Goldfinch Bio focused on kidney diseases, Karuna believes its experimental drugs may have potential treating psychiatric and neurological conditions

Drugs 241
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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

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]).

Genetics 130
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FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

Bio Pharma Dive

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

Antibody 220
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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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Can You Sue Your Doctor for Blindness Caused by Elmiron®?

Pharma Mirror

The Janssen Pharmaceuticals-produced medication Elmiron® is used to treat interstitial cystitis. Elmiron may be connected to eye damage that results in vision loss or other negative effects like blurry vision, according to some studies.

Doctors 130
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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

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US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months.

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So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

The FDA Law Blog

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.

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Pressure's on, GSK. Merck's Keytruda drops endometrial cancer win in first-line treatment

Fierce Pharma

Pressure's on, GSK. Merck's Keytruda drops endometrial cancer win in first-line treatment aliu Fri, 02/03/2023 - 09:43

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Endevica Bio and Orbit Discovery unite to boost cachexia therapeutics

Pharma Times

The central focus of the agreement is to establish peptide hits from selected library populations

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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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Biotech startup Structure pulls off rare IPO, raising $161M

Bio Pharma Dive

The company’s lead drug could be an oral alternative to marketed diabetes and obesity drugs from Novo Nordisk and Eli Lilly

Drugs 236
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Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

The field of genomic medicine has reached a true turning point.

Genome 206
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Roche announces positive data from global phase III programme for crovalimab in PNH, a rare life-threatening blood condition

The Pharma Data

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Pfizer warns Comirnaty sales will plummet by nearly two-thirds in 2023. And Paxlovid won't fare much better

Fierce Pharma

Pfizer warns Comirnaty sales will plummet by nearly two-thirds in 2023. And Paxlovid won't fare much better kdunleavy Tue, 01/31/2023 - 10:58

Sales 97
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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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Sanofi’s efanesoctocog alfa may be game-changer for haemophilia A patients

Pharma Times

Phase 3 study demonstrated that efanesoctocog alfa met both primary and secondary endpoints

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GSK moves hepatitis B drug into late-stage testing

Bio Pharma Dive

The British drugmaker sees potential for the medicine to be a functional cure for chronic infections, and is beginning two Phase 3 trials to test its promise

Trials 234
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uniQure signs license deal for Apic Bio’s gene therapy for SOD1-ALS

Pharmaceutical Technology

Gene therapy company uniQure has entered into a global licensing agreement with Apic Bio for APB-102 to treat patients with amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1).

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Maximizing patient recruitment for rhinosinusitis trials in a competitive market

Clairnes

The post Maximizing patient recruitment for rhinosinusitis trials in a competitive market appeared first on Clinical Trial Recruitment & Management Services.

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Novo's Rybelsus comes into its own as Wegovy shakes off supply constraints

Fierce Pharma

Novo's Rybelsus comes into its own as Wegovy shakes off supply constraints fkansteiner Thu, 02/02/2023 - 08:57

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Cambridge Cognition and Aardex collaborate to boost decentralised clinical trials

Pharma Times

Partnership involves the study of real-time patient data and identification of adherence issues

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A startup launches with plans to open up a gene and cell therapy bottleneck

Bio Pharma Dive

The pipeline of CAR-T therapies and ex vivo gene therapies has swelled in recent years, but manufacturing hasn’t been able to keep up with demand

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Pfizer reports 30% operational growth in full-year 2022 revenues

Pharmaceutical Technology

Pfizer has reported a 30% operational growth in revenues to $100.3bn in full-year 2022 compared with $81.2bn reported last year. The revenues grew 2% operationally excluding Paxlovid and Comirnaty’s contributions.

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Aptamer partners with Hong Kong biotech to develop targeted gene therapies

BioPharma Reporter

UK based, Aptamer Group, and Hong Kong headquartered, BaseCure Therapeutics, are paring up on the development of Optimer-targeted gene therapies. Markets & Regulations

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

The FDA Law Blog

By Mark A. Tobolowsky & Charles G.

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AlzeCure’s neuropathic pain candidate study reaches crucial phase

Pharma Times

Research concerns ACD440 – a non-opioid drug which treats peripheral neuropathic pain

Drugs 100
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Humira biosimilars arrive in the US, as Amgen launches first copycat to AbbVie’s blockbuster drug

Bio Pharma Dive

The world’s best-selling drug will face pricing pressure as rivals try to steal share away from AbbVie’s $20 billion-a-year flagship product in the U.S.

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Merck reports 2% increase in worldwide sales in Q4 2022

Pharmaceutical Technology

Merck (MSD outside North America) has reported a 2% increase in worldwide sales to $13.83bn in the fourth quarter (Q4) of 2022 from $13.52bn in the previous year’s quarter. The company’s pharmaceutical sales recorded a 1% rise to $12.18bn compared to $12.03bn in the prior-year quarter.

Sales 201
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Medical Device Coatings and Modification Technologies

Roots Analysis

Medical Device Coatings – From Supplementary Protection Constituents to Necessary Tools for Various Functions Over the past 50 years, the medical device industry has seen several notable developments.

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Bionova Scientific Begins Plant Expansion Project

Pharmaceutical Commerce

CDMO is commissioning third GMP biologics facility in Fremont.

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BaseCure collaborates with Aptamer Group to boost gene therapies

Pharma Times

Binders will establish cell types and delivery vehicles may increase uptake of the siRNA therapy

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COVID-19 vaccine maker Medicago to close down

Bio Pharma Dive

The company, which worked with GSK to develop a coronavirus shot, is ceasing operations after its corporate parent cut off further investment

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Magazine: CRISPR gene therapies cut through in 2023

Pharmaceutical Technology

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia.

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Jazz wins reimbursement nod from NICE for cannabinoid med Epidyolex

Fierce Pharma

Jazz wins reimbursement nod from NICE for cannabinoid med Epidyolex kdunleavy Wed, 02/01/2023 - 10:19

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Jaypirca (pirtobrutinib) Is Now FDA Approved to Treat Relapsed or Refractory Mantle Cell Lymphoma

XTalks

Loxo Oncology (Eli Lilly and Company) recently announced that their Bruton tyrosine kinase inhibitor (BTKi), Jaypirca (pirtobrutinib), was approved by the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory mantle cell lymphoma (R/R MCL) under the Accelerated Approval pathway.