Sat.Jul 30, 2022 - Fri.Aug 05, 2022

Alnylam drug succeeds in key heart disease study, boosting company

Bio Pharma Dive

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application

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Should you take a job with a biotech startup?

World of DTC Marketing

At first, the opportunity to join a small biotech startup sounds excellent. Smaller staff usually means less bureaucracy and being on the ground floor of a potentially financially rewarding career. But there are risks.

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Trending Sources

Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources.

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

The FDA Law Blog

By Sophia R. Gaulkin & Alan M. Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS).

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.

How a small UK biotech ended up in Gilead’s hands

Bio Pharma Dive

MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research

Healthcare stories in the news

World of DTC Marketing

Democrats have been campaigning for 30 years on promises they’d let Medicare directly negotiate the cost of prescription drugs. Now, after the majority of voters want reduced costs for their prescription drugs, the bill seems ready to pass despite record pharma lobbying.

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It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

FDA Law Blog

By Jeffrey N. Gibbs & Allyson B. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you.

Roche digs into off-the-shelf cell therapy with Poseida deal

Bio Pharma Dive

The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives

Drugs 279

Are online health searches private?

World of DTC Marketing

A Gizmodo investigation into some of the nation’s biggest data brokers found more than two dozen promoting access to datasets containing digital information on millions of pregnant and potentially pregnant people across the country.

No drugs for prions: could new approaches alleviate therapeutic scarcity?

Pharmaceutical Technology

The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. Also referred to as prion diseases, TSEs are rare and fatal neurodegenerative conditions.

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.

Biden Administration Facing Renewed Pressure to Legalize Cannabis

FDA Law Blog

By Larry K. Houck — At least one public interest group and several members of Congress remain frustrated with the Biden Administration’s failure to take action to legalize cannabis.

IDRx, a new biotech startup, raises $122M to develop better cancer drug combinations

Bio Pharma Dive

Founded by serial entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines

Pfizer, riding high on COVID windfall, eyes $5B play for Global Blood Therapeutics: WSJ

Fierce Pharma

Pfizer, riding high on COVID windfall, eyes $5B play for Global Blood Therapeutics: WSJ. esagonowsky. Fri, 08/05/2022 - 12:22

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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222.

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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.

Intertwining Technology and Data Solutions

Pharmaceutical Commerce

A look into the effectiveness of data processing pipelines.

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AbCellera inks another venture partnership, this time with Atlas

Bio Pharma Dive

One week after striking a deal with Versant, the antibody specialist is teaming up with Atlas to provide drug candidates to an undisclosed startup backed by the biotech investor

In historic FDA nod, AstraZeneca, Daiichi’s Enhertu snags ultrafast approval in broad HER2-low breast cancer use

Fierce Pharma

In historic FDA nod, AstraZeneca, Daiichi’s Enhertu snags ultrafast approval in broad HER2-low breast cancer use. Fri, 08/05/2022 - 14:27

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North America is seeing a hiring boom in pharmaceutical industry machine learning roles

Pharmaceutical Technology

North America extended its dominance for machine learning hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 63.9% of total machine learning jobs - up from 62.6% in the same quarter last year.

Blending human knowhow, artificial intelligence aids drug discovery

Outsourcing Pharma

A leader from pharmaceutical firm Astellas discusses how the company has put to use a discovery platform that combines human expertise, AI, and robotics. Preclinical Research

Drugs 101

Lilly takes long view on Alzheimer’s drug hopeful as FDA starts expedited review

Bio Pharma Dive

The pharma disclosed Thursday the FDA had accepted its application for donanemab, starting a six-month assessment for potential accelerated approval

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Merck's Keytruda, on a losing streak, fails in once FDA-rejected liver cancer use and prostate cancer—again

Fierce Pharma

Merck's Keytruda, on a losing streak, fails in once FDA-rejected liver cancer use and prostate cancer—again. Wed, 08/03/2022 - 11:22

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Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Last year, the companies entered a strategic collaboration.

Connecting EHR to clinical trials: How to embrace the promise of real-world data

Pharma Phorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back?

Concert to seek approval for hair loss drug after second study success

Bio Pharma Dive

The biotech plans to file an application with the FDA in the first half of next year for clearance in alopecia areata, potentially positioning it to compete with Eli Lilly and Pfizer for market share

Pfizer, Moderna deals for revamped COVID shots won’t be enough without more funding, HHS says

Fierce Pharma

Pfizer, Moderna deals for revamped COVID shots won’t be enough without more funding, HHS says. fkansteiner. Mon, 08/01/2022 - 08:17

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Building a global supply chain network for clinical trial products

Pharmaceutical Technology

Clinical trial design continues to increase in complexity, and temperature-controlled logistics – in particular cold chain and frozen and associated supply chains – must also advance to keep pace with technological developments.

Seqster, Boehringer Ingelheim, Partner up on Patient Engagement

Pharmaceutical Commerce

Multi-year deal aims to put patients at the center of their clinical data.

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Amgen bets almost $4B on a biotech and its inflammation drugs

Bio Pharma Dive

The deals hands Amgen a few clinical programs and a marketed therapy in Tavneos, which was approved last year to treat a group of autoimmune diseases

Despite drug launch streak, Lilly posts rare sales decline as Alimta succumbs to generics

Fierce Pharma

Despite drug launch streak, Lilly posts rare sales decline as Alimta succumbs to generics. esagonowsky. Thu, 08/04/2022 - 09:03

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AbbVie reports 4.5% rise in Q2 2022 net revenues

Pharmaceutical Technology

AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter.

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Keytruda fluffs its lines in prostate, liver cancer trials

Pharma Phorum

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair.

FDA approves AstraZeneca, Daiichi drug in breast cancer first

Bio Pharma Dive

Enhertu is the first targeted treatment cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease

Lilly, AZ, AbbVie and J&J face big potential hit from Medicare pricing bill: analysts

Fierce Pharma

Lilly, AZ, AbbVie and J&J face big potential hit from Medicare pricing bill: analysts. esagonowsky. Mon, 08/01/2022 - 09:25

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Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

Amgen has signed a definitive agreement to acquire biopharmaceutical company ChemoCentryx for $52 for each share in cash or a total enterprise cost of nearly $3.7bn. ChemoCentryx focuses on orally administered therapeutics for the treatment of inflammatory disorders, autoimmune ailments and cancer.