December, 2022

FDA approves first microbiota-based treatment

Bio Pharma Dive

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection

Get Set up for Success in the Account Incubator Program

Intouch Solutions

Finding an agency job after graduating college can feel overwhelming, but it doesn’t have to. Jumpstart your career at EVERSANA INTOUCH and be set up for success as part of our Account Incubator program where you can dip your toes into an Account Services role!

Insiders

Sign Up for our Newsletter

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

Trending Sources

Third Circuit Court of Appeals Upends “Intended Loss”

The FDA Law Blog

By Douglas B. Farquhar & John W.M.

The European Commission and WHO extend their strategic cooperation to deliver better health for all

The Pharma Data

The European Commission and WHO extend their strategic cooperation to deliver better health for all.

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.

Elon Musk’s Neuralink brain interface chip set for human trials

Pharma Phorum

Clinical trials of a wireless brain chip developed by Elon Muck’s Neuralink company will be tested in human volunteers within the next six months – and Musk himself says he intends to have one implanted for a future demo event.

With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker

Fierce Pharma

With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker. fkansteiner. Fri, 12/02/2022 - 09:51

Drugs 94

More Trending

Protracted Job Searches Exact Weighty Mental Health Toll

BioSpace

Whether a job search is voluntary or not, the psychological toll of months of interviews, wrangling over pay and benefits and evaluating options has a weighty psychological toll

86

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

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 61

Addressing leadership barriers for women in tech and pharma

Pharma Phorum

Contrary to Big Tech, historically the pharmaceutical industry has had a good reputation for being a female-positive industry. However, both industries share a common problem: failure to provide women with C-suite opportunities.

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.

With FDA nod for its fecal microbiome therapy, Ferring becomes No. 1 in No. 2

Fierce Pharma

With FDA nod for its fecal microbiome therapy, Ferring becomes No. 1 in No. kdunleavy. Thu, 12/01/2022 - 10:14

91

Rigel wins US approval of rival drug to Servier leukemia treatment

Bio Pharma Dive

The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo

GSK Notches Phase III Win for Jemperli in Endometrial Cancer

BioSpace

???????GSK intends to file for approval of Jemperli in endometrial cancer after the checkpoint inhibitor met its primary endpoint in the Phase III RUBY trial

Sanofi and Queensland collaborate to build $190m research facility

Pharmaceutical Technology

Sanofi has signed an agreement with the Queensland Government in Australia to establish a $190m (A$280m) research facility in Brisbane. With the establishment of this Translational Science Hub, Queensland is set to become an international messenger ribonucleic acid (mRNA) vaccine hub.

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.

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 56

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.

PureTech readies oral CBD capsule for clinic to challenge Jazz’s Epidiolex

Fierce Pharma

PureTech readies oral CBD capsule for clinic to challenge Jazz’s Epidiolex. ntaylor. Thu, 12/01/2022 - 11:05

90

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

PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex

XTalks

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups.

Cannabinoids receptors: popular preclinical target but banned in 137 countries

Pharmaceutical Technology

Cannabinoid receptors are a popular therapeutic target for cannabinoid-based drugs in the treatment of pain, neurological disorders and inflammation, according to GlobalData’s Pharma Intelligence Centre Drugs database.

FDA Outlines Path Forward for Verve’s Lead Candidate, VERVE-101

BioSpace

Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101

81

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

Pharma Phorum

GSK, Sanofi, Pfizer and Boehringer Ingelheim free from federal Zantac litigation with new ruling

Fierce Pharma

GSK, Sanofi, Pfizer and Boehringer Ingelheim free from federal Zantac litigation with new ruling. zbecker. Wed, 12/07/2022 - 10:05

82

Novartis prostate cancer drug succeeds in study key to company’s sales hopes

Bio Pharma Dive

The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market

Sales 246

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

Sanofi to showcase new data from oncology portfolio spanning marketed products and investigational compounds at ASH 2022

The Pharma Data

Sanofi to showcase new data from oncology portfolio spanning marketed products and investigational compounds at ASH 2022. Data featured at the 64 th American Society of Hematology (ASH) Annual Meeting & Exposition from December 10-13, 2022, reinforce Sanofi’s commitment to transforming care for people living with multiple myeloma (MM) and other difficult-to-treat blood cancers. Peter C.

SonoThera Bags $60M for Ultrasound-Guided, Non-Viral Gene Therapy

BioSpace

???????SonoThera closed its Series A round of financing Monday, counting $60.75 million in earnings and will use these proceeds to advance its ultrasound-guided, non-viral gene therapy platform

Valneva eyes first place in chikungunya vaccine race

Pharma Phorum

Valneva has moved a step closer to its goal of becoming the first company to file for approval of a vaccine against chikungunya virus in the US after reporting new clinical data today.

UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer

Fierce Pharma

UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer. zbecker. Fri, 12/02/2022 - 11:22

FDA lifts pause on Beam plans to test base editing cancer therapy

Bio Pharma Dive

The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously

Gene 252

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

European Medicines Agency accepts marketing authorization application for momelotinib for the treatment of myelofibrosis

The Pharma Data

European Medicines Agency accepts marketing authorization application for momelotinib for the treatment of myelofibrosis. GSK plc (LSE/NYSE: GSK). announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for momelotinib, a potential new oral treatment for myelofibrosis.

FUJIFILM Diosynth Biotechnologies: There’s a New Cell Therapy Employer in Thousand Oaks

BioSpace

FUJIFILM Diosynth Biotechnologies is offering unique opportunities to join one of the top global CDMOs focused on solving some of the most complex healthcare challenges

80

New Nkarta data backs up natural killer approach to cancer treatment

Pharma Phorum

Harnessing the power of natural killer (NK) cells to attack cancer is as-yet an unproven strategy in oncology – but one that is garnering increased interest as clinical trials start to generate data.