Tue.Sep 14, 2021

Fourth trial volunteer dies in Astellas gene therapy study

Bio Pharma Dive

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used

Online health information: The game has changed

World of DTC Marketing

SUMMARY: Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.

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Biotech funder Lightstone raises another $375M for life sciences investing

Bio Pharma Dive

The venture firm, which previously invested in Disarm Therapeutics, Ra Pharma and Tizona Therapeutics, said its third fund surpassed its target

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.

CureVac scales back mRNA manufacturing for coronavirus vaccine

Bio Pharma Dive

The German biotech, which announced disappointing results for its shot in June, said the move was done in response to reduced demand

The tech revolution reshaping European healthcare

Pharma Phorum

The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC.

Gates Foundation, Exscientia enter $70m agreement to develop COVID-19 treatments

Outsourcing Pharma

The pharma tech firm has forged a four-year partnership with the foundation to develop antivirals for COVID-19 and other viruses with pandemic potential. COVID-19

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Study: Survivors of Severe COVID-19 at Risk for Autoimmune Disease

BioSpace

?According to the study, people who get sick enough to be hospitalized due to the virus might eventually suffer from a full-blown autoimmune disease later on

87

First subject dosed in psilocybin trial for rare headache disorder

Pharma Phorum

The first patient has received a low dose of Beckley Psytech’s psychedelic medicine psilocybin in a clinical trial for short-lasting unilateral neuralgiform headache attacks (SUNHA), a rare disorder.

Neuroprosthesis Gives Paralyzed Man His Voice Back

BioSpace

After multiple attempts, the setup successfully translated signals from his brain to the vocal tract in the form of words that appear as text on a screen

87

First patient receives low-dose psilocybin in rare headache disorder trial

Pharma Times

Phase Ib trial is evaluating the potential benefit of low-dose psilocybin as a treatment for SUNHA

U.S. FDA Grants Key Approvals to Potential Rare and Serious Disease Treatments

BioSpace

The U.S. FDA has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here's a look

86

New patent expiration for Pfizer drug ZYVOX

Drug Patent Watch

Annual Drug Patent Expirations for ZYVOX Zyvox is a drug marketed by Pfizer and is included in three NDAs. It is available from four suppliers. There are two patents protecting…. The post New patent expiration for Pfizer drug ZYVOX appeared first on DrugPatentWatch - Make Better Decisions.

FDA Reverses Course on NDA Submission for Amylyx ALS Drug

BioSpace

Amylyx’s decision to submit the NDA, announced Wednesday morning, came on the heels of recent discussions with the FDA, including a pre-NDA meeting held on July 15

Drugs 83

CureVac terminates COVID-19 vaccine manufacturing contracts with Wacker and Celonic

BioPharma Reporter

CureVac is streamlining its external European manufacturing network for its mRNA product pipeline; having reassessed demand for its first-generation COVID-19 vaccine candidate. Upstream Processing

Theravance Lays Off 270 in Aftermath of Cardiac Asset Failure

BioSpace

The company announced a Phase III cardiac drug failed to meet its primary endpoint and a significant shift in its R&D efforts that have resulted in the termination of 75% of its staff

Drugs 83

Pioneering Gene Therapy Freed Her of Sickle Cell. Is a Cure at Hand?

NY Times

Such treatments are extraordinarily promising and costly. Will the Biden administration commit to spending that could speed clinical trial results? Sickle Cell Anemia Drugs (Pharmaceuticals) Research Clinical Trials Genetic Engineering Genetics and Heredity Race and Ethnicity

COVID-19: Harsh Impacts, Downward and Upward Trends, and Innovation

BioSpace

Data coming in about the COVID-19 pandemic shows some promising overall trends, with other more disturbing ones, particularly in breakthrough infections of the fully vaccinated

Within3 launches new insights management platform

Pharma Times

Platform launched in a bid to help life sciences companies address the insights gap

ESMO Preview: Highlights to Watch for This Year

BioSpace

The European Society for Medical Oncology Congress 2021 runs from September 16–21, 2021. Here’s a preview of some of the presentations at the meeting

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Teatis Carb-Blocking Teas Aim to Help Diabetics Avoid Blood Sugar Spikes

XTalks

Teatis, a New-York based company, is the maker of superfood powders for diabetic consumers. They announced the close of their seed funding round last week, during which they raised $700,000, bringing the company’s total funding of $1 million. Hiroshi Takatoh is the entrepreneur behind this brand.

Brukinsa Accelerated Approval in Lymphoma Makes Two in a Row for BeiGene

BioSpace

Brukinsa was approved for MSL patients who have received at least one anti-CD20-based regimen

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New Texas Heart Institute study outlines additional reasons for optimism related to heart regeneration

Scienmag

Roche and Temedica Pilot Digital Companion for MS Patients

BioSpace

The mobile app, dubbed Brisa, has been designed to help patients record their disease progression regardless of condition and treatment plans

81

COVID-19 transmission risks rise during labor with patients’ heavier breathing

Scienmag

Some medical procedures can put health care workers at higher risk for contracting COVID-19 and other respiratory diseases. With these high-risk procedures, it’s important that health care providers have access to personal protective equipment (PPE), including N95 masks.

AI as Business Leverage in Pharma & Life Sciences

Pharma Phorum

If there was an AI solution in the Life Sciences field, able to represent a real opportunity in terms of Customer Engagement and Digital Transformation, and if some of the most important players in the industry already had it, would you like to have the opportunity to listen to them? . .

Americans’ civics knowledge increases during a stress-filled year

Scienmag

PHILADELPHIA – A growing number of Americans can name the branches of government and the freedoms under the First Amendment though many still misunderstand basic facts about how government works, according to the 2021 Annenberg Constitution Day Civics Survey.

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Money on the Move: September 8 – 14

BioSpace

Ramping up after the Labor Day holiday, funds are flowing fast and free into these life science companies

3D analysis of SARS-CoV-2 reveals clues on virus tactics

Scienmag

The most comprehensive analysis of the 3D structure of SARS-CoV-2 to date has revealed new insight on how the virus infects human cells and replicates.

Doctors believe in immunotherapy’s cancer-fighting potential: BMS survey

Outsourcing Pharma

A survey commissioned by Bristol Myers Squibb reveals healthcare providers are confident that immunotherapy can positively impact earlier-stage cancers. Markets & Regulations

England to offer COVID-19 jabs to 12- to 15-year-olds

Pharma Times

Children in this age group will be offered one dose of the Pfizer/BioNTech jab from next week

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6 of the Most Popular Job Qualifications (And How to Show You Have Them)

BioSpace

No matter what industry you work in, or at what level, there are certain soft skills that employers want to see

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SMC OKs three new meds in latest decisions

Pharma Times

Retsevmo, Keytruda and Jyseleca accepted for use by NHS Scotland

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Healthcare ‘heroes’ make decentralized clinical trials possible

Outsourcing Pharma

A physician assistant from Hawthorne Effect shares how she and other trained health professionals contribute their knowledge and talents to in-home studies. Clinical Development

Sensorion And Hearing Care Leader Sonova Sign Strategic Research Collaboration

BioTech 365

Life-sized camel carvings in Northern Arabia date to the Neolithic period

Scienmag

The monumental reliefs at the Camel Site in northern Arabia are unique: three rock spurs are decorated with naturalistic, life-sized carvings of camels and equids. In total, 21 reliefs have been identified.

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GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Clinical Trial of GS030 as Optogenetic Treatment for Retinitis Pigmentosa

BioTech 365

GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Clinical Trial of GS030 as Optogenetic Treatment for Retinitis Pigmentosa GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Clinical Trial of GS030 … Continue reading → Business Wire