Tue.Dec 06, 2022

article thumbnail

Biotech veteran Jeff Jonas on leaving Sage, guiding new biotechs and his ‘personal odyssey’

Bio Pharma Dive

In an interview with BioPharma Dive, the longtime industry executive discussed becoming a biotech investor and his plans for Abio-X, a new incubator with $150 million to spend on startups

275
275
article thumbnail

Managing drug shortages: Getting medicines to patients in need

Pharmaceutical Technology

Ongoing drug shortages are not a new occurrence, but a rise in shortages following the pandemic and other global events is leaving many patients unable to access the medicines they need.

Medicine 191
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Star Therapeutics launches Vega, growing its galaxy of drug startups

Bio Pharma Dive

The second startup to emerge from Star’s “hub-and-spoke” model aims to develop a Hemlibra-like antibody drug for the blood clotting disorder von Willebrand disease

Antibody 243
article thumbnail

MEI and Kyowa Kirin to discontinue development of zandelisib outside Japan

Pharmaceutical Technology

MEI Pharma and Kyowa Kirin have announced plans to discontinue the international development of investigational cancer therapy, zandelisib, for B-cell malignancies outside of Japan.

Trials 141
article thumbnail

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.

article thumbnail

Gene therapy approvals bring validation as field closes year on high

Bio Pharma Dive

It’s been a busy fall in gene therapy, with FDA nods for new treatments from CSL and Bluebird as well as a few deals. Catch up on our best stories here

article thumbnail

Monoclonal antibodies challenge marketed small-molecule Alzheimer’s dominance

Pharmaceutical Technology

The three leading Alzheimer’s disease (AD) drugs currently in development are all monoclonal antibodies—donanemab by Eli Lilly , lecanemab by Eisai and Biogen , and gantenerumab by Roche.

Antibody 141

More Trending

article thumbnail

Evaxion and ExpreS²ion partner to develop new CMV vaccine

Pharmaceutical Technology

Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate.

Licensing 130
article thumbnail

Karuna switches CEOs ahead of FDA filing for schizophrenia drug

Bio Pharma Dive

Former Allergan commercial executive Bill Meury will take over for longtime CEO Steve Paul as the company prepares to seek U.S. approval of the treatment, known as KarXT, next year

Drugs 175
article thumbnail

The rising importance of containment in small molecule drug development

Pharmaceutical Technology

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world.

article thumbnail

MEI, Kyowa stop lymphoma drug trials after FDA meeting

Bio Pharma Dive

The decision not to run a Phase 3 trial of their medicine is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs known as PI3 kinase inhibitors

article thumbnail

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.

article thumbnail

Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer

The Pharma Data

Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer.

Drugs 82
article thumbnail

Verve shares slide after company reveals details on FDA trial hold

Bio Pharma Dive

In a letter to the biotech, the regulator asked for more information on its gene editing medicine for heart disease as well as on its potential risks

article thumbnail

Novartis Kisqali® prolonged PFS benefit for pre- and perimenopausal patients with aggressive HR+/HER2? metastatic breast cancer compared to chemotherapy

The Pharma Data

Novartis Kisqali® prolonged PFS benefit for pre- and perimenopausal patients with aggressive HR+/HER2− metastatic breast cancer compared to chemotherapy. Novartis.

HR 82
article thumbnail

Spago Nanomedical begins endometriosis study

Pharma Times

Clinical trial has received regulatory approval and involves endometriosis candidate SN132D

article thumbnail

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.

article thumbnail

Licensing deal aimed at progressing cell and gene therapies in the treatment of rare diseases

BioPharma Reporter

Curamys, a South Korean biotech developing cell and gene therapy using cell fusion technology to treat rare intractable diseases, has signed a strategic platform licensing agreement with US tech developer, MaxCyte. Markets & Regulations

article thumbnail

LEO Pharma reveal positive results from delgocitinib research

Pharma Times

Phase 3 clinical trial focuses on adults with moderate-to-severe chronic hand eczema

article thumbnail

Bayer Launches Industry-First Public Database Listing Company’s Science Collaborations and Partnerships in the U.S.

The Pharma Data

Bayer Launches Industry-First Public Database Listing Company’s Science Collaborations and Partnerships in the U.S. Bayer announced the U.S. launch of the Bayer Science Collaboration Explorer (BSCE) as part of its ongoing efforts to enhance public trust in scientific innovations, processes, and R&D activities.

article thumbnail

Vaxxas raises $23M to fund needle-free COVID-19 vaccine trial

Fierce Pharma

Vaxxas raises $23M to fund needle-free COVID-19 vaccine trial. ntaylor. Tue, 12/06/2022 - 10:15

Trials 87
article thumbnail

Pfizer and Clear Creek Bio to Collaborate on a Research Program Targeting SARS-CoV-2 Papain-Like Protease

The Pharma Data

Pfizer and Clear Creek Bio to Collaborate on a Research Program Targeting SARS-CoV-2 Papain-Like Protease. Pfizer Inc. NYSE: PFE) and Clear Creek Bio, Inc. today announced a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19. PLpro is an essential enzyme, which, along with the main protease (Mpro), plays an important role in viral replication.

Genome 63
article thumbnail

Emergent snags speedy FDA review, potentially teeing up over-the-counter Narcan by next spring

Fierce Pharma

Emergent snags speedy FDA review, potentially teeing up over-the-counter Narcan by next spring. fkansteiner. Tue, 12/06/2022 - 10:58

87
article thumbnail

Announcement for the purposes of Rule 2.8 of the Irish Takeover Panel Act, 1997, Takeover Rules, 2022 (the “Irish Takeover Rules”)

The Pharma Data

Announcement for the purposes of Rule 2.8 of the Irish Takeover Panel Act, 1997, Takeover Rules, 2022 (the “Irish Takeover Rules”). FOR IMMEDIATE RELEASE. No intention to bid statement for Horizon Therapeutics plc (“Horizon”). Further to the announcement by Horizon on November 29, 2022, Janssen Global Services, LLC (“theCompany”) confirmed today that it does not intend to make an offer for Horizon. Accordingly, the Company will be bound by the restrictions set out in Rule 2.8

article thumbnail

Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s

Pharma Phorum

article thumbnail

Intravacc launches phase 1 trial for intranasal COVID-19 booster vaccine

BioPharma Reporter

Intravacc has enrolled the first participant in a phase I first in-human clinical trial of Avacc 10, the companyâs SARS-CoV-2 intranasal subunit vaccine, as a booster shot. Bio Developments

article thumbnail

Leo Pharma scores with its JAK inhibitor cream in chronic hand eczema trial

Fierce Pharma

Leo Pharma scores with its JAK inhibitor cream in chronic hand eczema trial. kdunleavy. Tue, 12/06/2022 - 10:04

Trials 86
article thumbnail

How a new investment is powering a revolution in clinical trial operations

Pharma Phorum

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past.

article thumbnail

GSK, Sanofi, and Takeda align with research communities to advance Singapore's biologics manufacturing capabilities

BioPharma Reporter

Global pharma giants, GSK, Sanofi, and Takeda, are set to collaborate with Singapore researchers to boost innovation in local biologics and vaccines manufacturing. Markets & Regulations

article thumbnail

Pfizer, BioNTech strike back at Moderna with mRNA vaccine patent lawsuit

Fierce Pharma

Pfizer, BioNTech strike back at Moderna with mRNA vaccine patent lawsuit. zbecker. Tue, 12/06/2022 - 11:27

article thumbnail

Evidence standard drawn up for digital therapeutics

Pharma Phorum

A model framework for generating the evidence to demonstrate the efficacy of digital therapeutics so they can secure regulatory approval and reimbursement has been published by a trade organisation representing digital health companies.

article thumbnail

Re-Vana reels in $12M to develop sustained-release eye implants

Fierce Pharma

Re-Vana reels in $12M to develop sustained-release eye implants. ntaylor. Tue, 12/06/2022 - 10:12

article thumbnail

CVS, Walgreens, and Walmart Keep Position in 2023 Part D Preferred Networks—While Kroger Bails Over its Express Scripts Blowup

Drug Channels

In Preferred Pharmacy Networks in 2023’s Medicare Part D Plans: Cigna, CVS Health, Humana, UnitedHealthcare, WellCare, and More , I highlighted how those networks have taken over the world of stand-alone Medicare Part D prescription drug plans (PDP) and become a major presence in Medicare Advantage prescription drug (MA-PD) plans.

Drugs 79
article thumbnail

Pfizer/BioNTech strike back in Moderna COVID vaccine lawsuit

Pharma Phorum

Pfizer and partner BioNTech have launched a countersuit against Moderna in a patent despite centring on their mRNA-based vaccines for COVID-19.

article thumbnail

Pfizer Catches Up to GSK as RSV Candidate Snags Priority Review

BioSpace

In the heated race for a new respiratory syncytial virus vaccine for older adults, Pfizer gained ground on GSK after winning priority review designation for its vaccine candidate

article thumbnail

CPI and 24 partners open £88m manufacturing innovation center

Outsourcing Pharma

The collaborators unveil the facility after combing ideas from pharma and technology sectors to develop more sustainable manufacturing processes. Contract Manufacturing & Logistics

article thumbnail

Paragon Births Apogee to Address Unmet Need in Immunology/Inflammatory Space

BioSpace

Apogee Therapeutics sprang onto the immunology/inflammatory scene Wednesday heavy on capital but light on salient details of the pipeline

67