Wed.Sep 15, 2021

After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Bio Pharma Dive

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months

Drugs 282

DTC messages need to evolve

World of DTC Marketing

SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times.

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Theravance to lay off 75% of employees alongside larger restructuring

Bio Pharma Dive

The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test

Drugs 264

FDA Approves First Human Trial for Potential CRISPR-Led HIV Cure

BioSpace

?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy

New data from Israel, Pfizer show potent effect from third coronavirus shot

Bio Pharma Dive

The much-anticipated data arrive two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine

EU ‘negotiating with Valneva’ over COVID-19 vaccine contract

Pharma Phorum

The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week.

FDA staff tight-lipped on booster shot views ahead of consequential meeting

Bio Pharma Dive

In a briefing document released Wednesday, agency reviewers did not make a strong case either for or against the broad authorization of boosters for the general public

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More Trending

US stocks up on COVID-19 antibody drugs amid shortage concerns

Bio Pharma Dive

Deals with Regeneron and Eli Lilly will secure nearly 1.8 million additional doses of the companies' respective treatments over the next four months

Retaining Biotech Employees in the New War for Talent

BioSpace

With multiple job openings across the industry, biotech and biopharma employers have to come up with different strategies to retain top talent

91

Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

NY Times

Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.

AI aims to prevent unneeded treatment for deep vein thrombosis

Pharma Phorum

Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily.

Global Roundup: TreeFrog Scores $75 Million, Establishes US Toehold

BioSpace

Biopharma and life sciences companies and organizations from across the globe provide updates on their businesses and pipelines

New patient coalition for digital tech in health launches

Pharma Times

Coalition unites a range of stakeholders across healthcare

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COVID-19 Update: Vaccines for Kids and an Upcoming Verdict on Boosters

BioSpace

FDA external advisors will meet to consider Pfizer and BioNTech data in support of booster shots. The two companies also expect to file for Vaccine Authorization for children in the coming months

Research identifies possible link between antibiotic use and breast cancer growth

Pharma Times

Researchers discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew

AbCellera Lands Hottest Fishing Partner Yet in Moderna

BioSpace

Moderna will leverage AbCellera’s AI-powered technology to search and analyze natural immune responses in the hopes of identifying antibodies for up to six targets

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

Pharma Phorum

Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy.

Takeda Racks Up Designations for Rare Lung Cancer Drug

BioSpace

?The FDA awarded a number of designations for Takeda's candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer

Drugs 82

NICE backs Opdivo for head and neck cancer

Pharma Times

New evidence collected through the CDF shapes recommendation

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Intellia Therapeutics Set to Enter Clinic with First Solo Ex Vivo Candidate

BioSpace

NTLA-5001 is being developed for the treatment of acute myeloid leukemia (AML

New patent for Novartis Pharms drug ENTRESTO

Drug Patent Watch

Annual Drug Patent Expirations for ENTRESTO Entresto is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Novartis Pharms drug ENTRESTO appeared first on DrugPatentWatch - Make Better Decisions.

4 Reasons People Will Change Their Jobs Post-Pandemic

BioSpace

According to Bloomberg, the Work Trend Index showed that 41% of the survey’s 30,000 respondents planned on leaving their current job

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Democrats’ Stumble on Drug Prices Shows Power of Industry

NY Times

An attempt in the House to take a bite out of drug companies meets resistance. Drugs (Pharmaceuticals) United States Politics and Government Federal Budget (US) Prices (Fares, Fees and Rates) Lobbying and Lobbyists

Drugs 78

EU Medical Device Safety Monitoring & Reporting Conference | October 26-28, 2021 | Berlin, Germany and Virtual

Pharma Marketing Network

Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape.

Know which is better – Azithromycin standalone V/s Azithromycin+Hydroxychloroquine

Druggist

Is azithromycin effective in the treatment of covid - what research says? Every effort is being made to prevent covid-19. But, the way the virus is continuously mutating, is a problem for both scientists and doctors.

Vifor Pharma and Travere Therapeutics announce licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand

BioTech 365

Vifor Pharma and Travere Therapeutics announce licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand Vifor Pharma and Travere Therapeutics announce licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand Sparsentan is … Continue reading → Business Wire

COVID-19 nasal vaccine candidate effective at preventing disease transmission

Scienmag

Breathe in, breathe out. That’s how easy it is for SARS-CoV-2, the virus that causes COVID-19, to enter your nose.

BIOCORP and MERCK Sign a Partnership in the Field of Human Growth Hormone (HGH)

BioTech 365

BIOCORP and MERCK Sign a Partnership in the Field of Human Growth Hormone (HGH) BIOCORP and MERCK Sign a Partnership in the Field of Human Growth Hormone (HGH) Biocorp and Merck will collaborate on the development and global distribution of … Continue reading → Business Wire

Aquarium-led landmark study finds some shark species are tougher than others when it comes to surviving catch and release

Scienmag

BOSTON, MASS. 15, 2021) – A new landmark study of over 300 sharks found that some species are extremely resilient to the stress of being caught and released in commercial longline fisheries while other species are much more likely to die. Credit: New England Aquarium BOSTON, MASS.

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BioUtah Statement on Biden Administration’s Proposed Repeal of Medicare Coverage of Innovative Technology Final Rule

BioTech 365

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Rare disease innovation and data sharing accelerated by new RDCA-DAP program

Scienmag

TUCSON, Ariz. and WASHINGTON, September 15, 2021 — The Rare Disease Cures Accelerator-Data and Analytics Platform initiative (RDCA-DAP®) officially launched its next phase on Tuesday establishing itself as the leading platform to accelerate rare disease treatment innovation.

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Aurinia Pharmaceuticals to Present at Upcoming September Investor Conferences

BioTech 365

Aurinia Pharmaceuticals to Present at Upcoming September Investor Conferences Aurinia Pharmaceuticals to Present at Upcoming September Investor Conferences VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc.

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Rockefeller saliva test for COVID-19 outperforms commercial swab tests

Scienmag

In the early days of the pandemic, with commercial COVID tests in short supply, Rockefeller’s Robert B. Darnell developed an in-house assay to identify positive cases within the Rockefeller community.

Moderna Highlights New Clinical Data on its COVID-19 Vaccine

BioTech 365

Moderna Highlights New Clinical Data on its COVID-19 Vaccine Moderna Highlights New Clinical Data on its COVID-19 Vaccine mRNA-1273 remains highly effective against COVID-19 in real-world effectiveness study during surge in Delta cases New analysis of open-label portion of Phase … Continue reading → Business Wire

Study reveals how ribosomes are assembled in human cells

Scienmag

All cells need ribosomes to make the proteins necessary for life. These multi-component molecular machines build complex proteins by stitching building blocks together according to instructions encoded in the cell’s messenger RNAs.

Aerie Pharmaceuticals Announces Novel Dry Eye Product Candidate AR-15512 (TRPM8 Agonist) Ophthalmic Solution Achieved Statistical Significance Over Multiple Symptoms and Signs in Successful Phase 2b Clinical Study for the Treatment of Dry Eye Disease

BioTech 365

Aerie Pharmaceuticals Announces Novel Dry Eye Product Candidate AR-15512 (TRPM8 Agonist) Ophthalmic Solution Achieved Statistical Significance Over Multiple Symptoms and Signs in Successful Phase 2b Clinical Study for the Treatment of Dry Eye Disease Aerie Pharmaceuticals Announces Novel Dry Eye … Continue reading → Business Wire

Scientists from Pusan National University emphasize the health benefits of ginseng

Scienmag

Ginseng, a widely popular superfood, has long been used in traditional medicine. The health benefits of ginseng are largely attributed to compounds called ginsenosides, which are present in the roots, stems, and leaves of the plant.