Amgen takes on Novartis with new heart drug data

Today's Big News

Nov 7, 2022

Life beyond COVID: BioNTech lines up 5 infectious disease vaccine trials for 2023

UPDATE: Flagship-founded Repertoire reveals culls, cuts and a new CEO marking dismal clinical start

With new data in hand, Amgen plans to take heart drug into phase 3 to challenge Novartis

Verve's momentum slows as high cholesterol gene editing therapy placed on hold by FDA

Inhibikase stock sinks on FDA's unexpected clinical hold for lead asset's Parkinson's trial

Mapping brain genes in autism finds widespread changes, especially in visual regions

 

Featured

Life beyond COVID: BioNTech lines up 5 infectious disease vaccine trials for 2023

It may have made its name—and fortune—with a COVID shot, but mRNA pioneer BioNTech is thinking bigger for 2023, with up to five trials for infectious disease vaccines set to enter the clinic.
 

Top Stories

UPDATE: Flagship-founded Repertoire reveals culls, cuts and a new CEO marking dismal clinical start

Flagship-founded Repertoire Immune Medicines is completely reshuffling following news that it had laid off nearly half of its staff. The company disclosed Monday that it had culled its top two assets and was replacing its founding CEO.

With new data in hand, Amgen plans to take heart drug into phase 3 to challenge Novartis

With fleshed-out phase 2 data, Amgen says it will launch a phase 3 for its heart drug olpasiran by the end of this year.

Verve's momentum slows as high cholesterol gene editing therapy placed on hold by FDA

Verve Therapeutics’ lead gene editing candidate has lost some steam after running into an FDA clinical hold.

Inhibikase stock sinks on FDA's unexpected clinical hold for lead asset's Parkinson's trial

Inhibikase Therapeutics has been left stumped and its stock sunk after the FDA unexpectedly placed a clinical hold on its midstage Parkinson’s drug.

Mapping brain genes in autism finds widespread changes, especially in visual regions

An effort to map the way the brains of those with autism are genetically unique from neurotypical individuals has found that the differences go well beyond regions involved in social behavior and language.

Fierce Healthcare's 2022 Women of Influence Awards

We're honoring 10 women making a difference in pushing healthcare to the future. This year's list covers the breadth of the industry, from providers to payers to health tech, and represents some of the industry's largest companies as well as up-and-coming innovators.

GSK's CAR-T rival Blenrep fails multiple myeloma trial, endangering its accelerated approval

GSK’s dream just turned into a nightmare. The company's BCMA-targeted Blenrep has failed in a phase 3 multiple myeloma trial, putting its accelerated approval in jeopardy.

AHA: Verily's Onduo virtual care app improves glucose, cholesterol in Type 2 diabetes patients

These days, employer-sponsored wellness programs are a dime a dozen—but Verily may have hit the jackpot with its own Onduo virtual care platform.

Novartis unveils yet another antibiotics expansion, this time plugging $50M into Sandoz's penicillin production

After similar moves in 2020 and 2021, Novartis’ generics arm on Monday said it would plug another 50 million euros (about $49.92 million) into its European production in a bid to boost capacity for finished dose form penicillins. In total, Sandoz has planned more than 250 million euros of investments in its continental antibiotics network.

Children's hospitals want Congress to fund mental health, workforce and coverage protections before year-end

The Children's Hospital Association penned a letter of lame duck requests that included hundreds of millions for pediatric workforce training, the passage of legislation improving kids' access to care and protections on healthcare coverage for children.

Boehringer taps former Novartis leader to fill chief medical officer position

Boehringer Ingelheim has snagged former Novartis leader and Big Pharma vet Lykke Hinsch Gylvin, M.D., to serve as the company’s chief medical officer and head of global medicine.
 
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‘The Top Line’: Philips' plans to cut costs to come back from its ventilator recalls

This week on “The Top Line,” we dig into Philips’ revelation that it is laying off 4,000 workers and planning for even more restructuring.
 

Resources

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Webinar: Writing the Future of Antibody Discovery Solutions

Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

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Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

Learn more about adaptive ascending dose escalation designs and considerations for determining the optimal approach to meet your drug development objectives
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Discover why you should choose the Gibco™️ Efficient-Pro™️ system

Revolutionize your monoclonal antibody (mAb) manufacturing process with the Gibco™️ Efficient-Pro™️ Medium and Feed System. Watch our how-to video.
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What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?
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Versatility of Softgel Technology - Encapsulation of a Volatile Compound

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Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?
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Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.
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The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.
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Softgel Formulation Enables Oral Delivery of Testosterone

Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy.
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Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success.
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Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities
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Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?
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Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?
 

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