Sun.Oct 10, 2021

Alzheimer’s Drug Granted FDA Breakthrough Designation as Space Heats Up

BioSpace

?The decision is based on promising results from the Marguerite RoAD and SCarlet RoAD open-label extension trials, showing a significant reduction in brain amyloid plaque in Alzheimer's patients

Patients with kidney transplants more vulnerable to common, usually harmless bacterium

Scienmag

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GSK Continues to Switch Up Scenery in Advance of Upcoming Demerger

BioSpace

The scenery will continue to change for GlaxoSmithKline as the company’s planned demerger looms on the horizon. On Monday, GSK gave a glimpse of where the companies will call home post-split

84

Ipsen appoints Mari Scheiffele as EVP and President, Specialty Care International

BioTech 365

52

Moving Quickly, Merck Submits COVID-19 Antiviral for FDA Approval

BioSpace

If authorized, it could be available in the U.S. before the end of the year. It is also working to submit applications to other regulators worldwide

CatalYm Presents Updated Tolerability and Preliminary Pharmacodynamics Data from GDF-15 Targeting First-in-Human Clinical Trial in Plenary Session at AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics

BioTech 365

Supernus Snags Parkinson’s-focused Adamas Pharmaceuticals in $400 Million Deal

BioSpace

Shares of Adamas Pharmaceuticals are up nearly 75% this morning after Supernus Pharmaceuticals announced it was acquiring the company and its Parkinson’s disease products

More Trending

Fauci Gives Go-Ahead to Trick-or-Treaters and More COVID-19 News

BioSpace

According to Fauci, kids can safely go trick-or-treating outdoors this Halloween. He did add that children who are eligible for COVID-19 vaccinations should do so for an “extra degree of protection

Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the GeneSight® Mental Health Monitor nationwide survey

Scienmag

Many Americans are experiencing anxiety symptoms as a result of the pandemic. Yet, one in five say they won’t seek treatment for mental health conditions and others say they won’t get help until these symptoms take a toll in their lives.

52

Senate Trims Massive Spending Bill, Snipping Out Biden’s Cancer-Ending Agency

BioSpace

Biden’s campaign trail promise to cure cancer is hanging in the balance as his plan for a new biomedical research agency is being axed from the Democrats’ social spending package

BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma in Australia

BioTech 365

52

Ensoma Taps Gene Therapy Leader as First CEO

BioSpace

After guiding BlueRock Therapeutics and its potential Parkinson’s disease stem cell therapy into the clinic and to a $1 billion acquisition by Bayer, Emile Nuwaysir is taking on gene therapy startup Ensoma as CEO

BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma

BioTech 365

BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma Marks BRUKINSA’s second approved indication in Australia, on the heels of its recent initial … Continue reading → Business Wire

52

FDA Greenlights Enzyvant Drug for Ultra-Rare Pediatric Disease

BioSpace

The incidence of congenital athymia is about 17 to 24 lives births each year in the U.S. The therapy is a one-time regenerative tissue-based therapy

Drugs 80

Kaneka Releases PCR Test Kit for COVID-19 Variants

BioTech 365

Kaneka Releases PCR Test Kit for COVID-19 Variants Kaneka Releases PCR Test Kit for COVID-19 Variants – Test kit capable of detecting four variants with a single PCR test – TOKYO–(BUSINESS WIRE)–Kaneka Corporation (TOKYO:4118) has released KANEKA RT-PCR Kit SARS-CoV-2 … Continue reading → Business Wire

52

Qpex is Moving Quickly to Combat Antimicrobial Resistance

BioSpace

Antimicrobial-resistant pathogens may still be a bit off peoples’ radar, but the hard lessons learned from lack of preparation for the COVID-19 pandemic are clearly in the sights of Qpex

79

A new proposed scheme towards seamless detection of cutoff lows and preexisting troughs

Scienmag

Niigata, Japan- Cutoff lows are cold-core cyclones existing in the upper troposphere developing from precursory preexisting troughs that is ultimately cutoff from the connections with the polar source region, as shown in Image 1.

Protagonist Back in the Saddle with PV Drug as FDA Lifts Hold

BioSpace

Protagonist Therapeutics announced Monday morning that the FDA had removed the hold on PV drug candidate rusfertide, clearing the way for all trials to resume

Association Between Risk of COVID-19 in Nonimmune Individuals and Immunity in Family Members

JAMA Internal Medicine

This cohort study examines the spread of COVID-19 infection within family members living in the same residence with different levels of immunity

63

Clinical Catch-Up: October 4-8

BioSpace

Another busy week for clinical trial news. Here’s a look

Limbix’ digital therapeutic cuts depression symptoms in young people

Pharma Phorum

Limbix is moving ahead with plans to file for FDA approval of its SparkRx digital therapeutic (DTx) for adolescents with symptoms of depression after reporting positive results in a clinical trial.

Pacira Adds Flexion's Zilretta to Non-Opioid Pipeline in $427 Million Deal

BioSpace

Zilretta is the first treatment approved by the U.S. FDA for OA knee pain that uses extended-release microsphere technology

61

Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the GeneSight® Mental Health Monitor nationwide survey

BioTech 365

Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the GeneSight® Mental Health Monitor nationwide survey Americans’ anxiety impacted by the ongoing pandemic, yet 1 in 5 say they won’t seek treatment according to the … Continue reading → GlobeNewswire

40

Idorsia Drug Flops in Fabry Disease, Program's Future Pending

BioSpace

?Its Phase III MODIFY study had hoped to find a positive effect of its oral substrate reduction therapy lucerastat on adult patients who have been diagnosed with Fabry disease

Drugs 56

OXURION – Positive Phase 2 Part A THR-149 data shared at the America Society of Retinal Specialists (ASRS) Annual Scientific Meeting

BioTech 365

OXURION – Positive Phase 2 Part A THR-149 data shared at the America Society of Retinal Specialists (ASRS) Annual Scientific Meeting OXURION – Positive Phase 2 Part A THR-149 data shared at the America Society of Retinal Specialists (ASRS) Annual … Continue reading → GlobeNewswire

40

Bagging a Job in Pharma: Tips and Tricks

BioSpace

Before we look at the tips and tricks that can help you bag a job in pharma, we should look at the complications that you might face when getting the job

52

Idorsia announces the results of MODIFY, a Phase 3 study of lucerastat in Fabry disease

BioTech 365

Idorsia announces the results of MODIFY, a Phase 3 study of lucerastat in Fabry disease Idorsia announces the results of MODIFY, a Phase 3 study of lucerastat in Fabry disease Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland … Continue reading → GlobeNewswire

40

Flash FDA approval sends ChemoCentryx spiralling upwards

Pharma Phorum

ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor.

Biotest AG: Biotest identifies a benefit with trimodulin in a relevant subgroup of hospitalised COVID-19 patients

BioTech 365

DGAP-News: Biotest AG / Key word(s): Research Update 11.10.2021 / 07:00 The issuer is solely responsible for the content of this announcement. PRESS RELEASE Biotest identifies a benefit with trimodulin in a relevant subgroup of hospitalised COVID-19 patients – Complete … Continue reading → EQS Newsfeed

Which pharmaceutical companies have the largest patent portfolios?

Drug Patent Watch

A strong patent portfolio is at the core of branded pharmaceutical firms. Accordingly, one way to assess the relative strength of pharmaceutical firms is to compare their patent-counts. This chart…. The post Which pharmaceutical companies have the largest patent portfolios?

Evotec SE files registration statement for proposed offering of American Depositary Shares

BioTech 365

DGAP-News: Evotec SE / Key word(s): Miscellaneous 11.10.2021 / 07:30 The issuer is solely responsible for the content of this announcement. Hamburg, Germany, 11 October 2021: Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that it has … Continue reading → EQS Newsfeed

40

Point-of-Care Ultrasound—Visually Satisfying Medicine or Evidence-Based Medicine?

JAMA Internal Medicine

Point-of-care ultrasonography (POCUS) is the use of ultrasonography by clinicians to augment the physical examination and guide clinical decision-making at the bedside. It has become the standard of care for most common bedside procedures. However, while endorsed by the American College of Physicians and the Society of Hospital Medicine, its use for diagnostic purposes is not as firmly grounded in evidence demonstrating net benefit on patient outcomes

Vita 34 AG extends the acceptance period under PBKM exchange offer

BioTech 365

DGAP-News: Vita 34 AG / Key word(s): Miscellaneous 11.10.2021 / 08:00 The issuer is solely responsible for the content of this announcement. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, … Continue reading → EQS Newsfeed

40

Chance Pharmaceuticals Secures $30 Million Series C Funding to Advance Innovative Pipeline and Initiate Additional Business Collaborations

BioTech 365

Chance Pharmaceuticals Secures $30 Million Series C Funding to Advance Innovative Pipeline and Initiate Additional Business Collaborations Chance Pharmaceuticals Secures $30 Million Series C Funding to Advance Innovative Pipeline and Initiate Additional Business Collaborations HANGZHOU, China, Oct. 11, 2021 (GLOBE … Continue reading → GlobeNewswire

40

4D Molecular Therapeutics Presents Interim Results from the Ongoing 4D-125 Phase 1/2 Clinical Trial in Patients with Advanced X-linked Retinitis Pigmentosa at the ASRS Annual Meeting

BioTech 365

4D Molecular Therapeutics Presents Interim Results from the Ongoing 4D-125 Phase 1/2 Clinical Trial in Patients with Advanced X-linked Retinitis Pigmentosa at the ASRS Annual Meeting 4D Molecular Therapeutics Presents Interim Results from the Ongoing 4D-125 Phase 1/2 Clinical Trial … Continue reading → GlobeNewswire