Sat.Sep 03, 2022 - Fri.Sep 09, 2022

Alnylam details anticipated results from heart disease drug trial

Bio Pharma Dive

Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug

The current pharma business model is unsustainable

World of DTC Marketing

Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs.

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Trending Sources

Roche to acquire biopharma firm Good Therapeutics for $250m

Pharmaceutical Technology

Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash.

The discovery of a new and compounding cybersecurity threat to pharmacies

Pharma Phorum

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised.

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.

FDA advisers back Amylyx ALS drug, reversing earlier position

Bio Pharma Dive

Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month

Strict COVID lockdowns in France improved cardiovascular health

The Pharma Data

A new paper in European Heart Journal – Digital Health, published by Oxford University Press, indicates that social-distancing measures like total lockdown have a measurable impact on vascular health.

More Trending

Bridge Bio will use Brainomix AI in lung fibrosis trial

Pharma Phorum

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials.

How a top FDA official’s words helped push a closely watched ALS drug toward approval

Bio Pharma Dive

Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review

Biosense Webster Launches the OCTARAY™ Mapping Catheter with TRUEref™ Technology

The Pharma Data

The OCTARAY ™ Mapping Catheter with TRUEref ™ Technology provides croakers with the precise information demanded for catheter ablation procedures that treat cardiac arrhythmias( 1),( 2),( ‡) IRVINE, CA – September 6, 2022 – Biosense Webster,Inc.,

Drugs 74

China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

Pharmaceutical Technology

The National Medical Products Administration of China (NMPA) has approved CanSino Biologics ’ (CanSinoBIO) recombinant Covid-19 vaccine (Adenovirus Type 5 Vector) for inhalation, Convidecia Air, as a booster.

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.

Benchling launches purpose-built tools to accelerate RNA R&D

BioPharma Reporter

Technology firm, Benchling, has developed what it calls the biopharma industryâs first set of full capabilities for designing, modelling, and studying both natural and chemically modified RNA in a single platform. Bio Developments

RNA 96

Relay impresses with early study data for targeted cancer drug

Bio Pharma Dive

Updated data released ahead of the ESMO medical conference suggest Relay’s medicine could be more effective than others like it in treating a type of bile duct cancer

FDA grants Breakthrough Therapy Designation to Pfizer’s Group B Streptococcus vaccine candidate

The Pharma Data

PfizerInc.( NYSEPFE) moment blazoned that its investigational Group B Streptococcus( GBS) vaccine seeker, GBS6 or PF- 06760805, entered Advance remedy Designation from theU.S.

Bayer agrees to pay $40m to resolve claims on three drugs

Pharmaceutical Technology

Bayer has agreed to make a payment of $40m for settling claims over the alleged violations of the False Claims Act linked to three drugs, Trasylol, Avelox and Baycol, the US Department of Justice said in a press statement.

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.

ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing

Fierce Pharma

ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing. Wed, 09/07/2022 - 15:14

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Roche to pay $250M for Good Therapeutics and its targeted drug technology

Bio Pharma Dive

The team behind the Seattle-based startup will launch a new company, Bonum Therapeutics, after the sale to Roche is completed

Sales 239

Allergan Aesthetics Celebrates 100 Million Syringes of JUVÉDERM®

The Pharma Data

Allergan Aesthetics, an AbbVie company( NYSE ABBV), blazoned its manufacturing installation in France has reached the corner of producing and dispatching 100 million hypes of JUVÉDERM ® products encyclopedically.

Gatehouse Bio and AstraZeneca to develop RNA therapeutics for heart failure

Pharmaceutical Technology

US-based biotech company Gatehouse Bio is extending its collaboration with AstraZeneca for developing RNA therapeutics to treat heart failure with preserved ejection fraction (HFpEF).

RNA 83

AstraZeneca, Merck's Lynparza rejected by NICE in prostate cancer over pricing—again

Fierce Pharma

AstraZeneca, Merck's Lynparza rejected by NICE in prostate cancer over pricing—again. zbecker. Wed, 09/07/2022 - 11:26

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Drugging RNA with pills: small molecules for a big frontier

Bio Pharma Dive

A handful of startups have formed in recent years with plans to target RNA with small molecules. Many have caught the attention of big drugmakers

RNA 241

ProAir® Digihaler® (albuterol sulfate) Inhalation Powder and Digihaler System to Help Improve Asthma Management

The Pharma Data

Results from the study showed a dults and children aged 13 and older with uncontrolled asthma using the ProAir Digihaler and its integrated system had 85.3% higher odds of improving their asthma control after three months compared with those using standard of care albuterol inhalers.

Tetra and Cellvera partner to develop oral Covid-19 treatment

Pharmaceutical Technology

Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez.

RNA 82

Former J&J executive settles with company in workplace discrimination lawsuit

Fierce Pharma

Former J&J executive settles with company in workplace discrimination lawsuit. zbecker. Thu, 09/08/2022 - 11:32

91

After safety setbacks, job cuts, Imara sells its top drug to a startup

Bio Pharma Dive

The biotech, which has lost nearly all of its value since going public in 2020, reached a deal to sell a drug it tested in sickle cell disease to Cardurion Pharmaceuticals, a richly funded startup focused on cardiovascular research

Forxiga approved in China for the treatment of chronic kidney disease in patients at risk of progression with and withouttype-2 diabetes

The Pharma Data

Approval marks the first SGLT2 inhibitor approved in China for chronic kidney disease in adult patients with and without type-2 diabetes.

US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin.

NICE says no to Lynparza in prostate cancer, creating UK access divide

Pharma Phorum

NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price with the drugmaker.

Regeneron answers rivals with data for new version of top-selling eye drug

Bio Pharma Dive

A high-dose form of Eylea, administered less frequently, matched the original in late-stage testing, an important step in the company’s plan to defend its bestseller against competition

Drugs 236

Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus

The Pharma Data

Bayer pays $40M to settle with whistleblower who said company violated False Claims Act

Fierce Pharma

Bayer pays $40M to settle with whistleblower who said company violated False Claims Act. kdunleavy. Tue, 09/06/2022 - 09:08

91

Pharma’s climate change vulnerability and opportunity

Pharma Phorum

As one of the world’s biggest contributors to climate change, pharma is morally obliged to adapt its processes and operations – and doing so will open up new opportunities for growth.

FDA names new head to vaccine review office

Bio Pharma Dive

David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters

Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer

The Pharma Data

Approval based on TOPAZ-1 Phase III trial results, which showed Imfinzi combination reduced risk of death by 20% vs. chemotherapy alone.

HR 71

Starbucks Names Laxman Narasimhan as New CEO

XTalks

Starbucks has appointed longtime Reckitt CEO and PepsiCo executive Laxman Narasimhan as their new CEO beginning October 1, 2022 after relocating from London to the Seattle area. Until then, he will work closely with interim CEO, Howard Schultz, through April 1, 2023.