Europe's drug regulator links J&J's vaccine to rare clots as US pause continues

Bio Pharma Dive

Regulators in the U.S. The EMA reiterated the vaccine's benefits outweigh its risks but recommended a warning be added to highlight the rare, but serious side effect. are expected to soon make a similar decision

FTC joins overseas antitrust regulators in examination of pharma M&A

Bio Pharma Dive

The commission, along with agencies in Europe, Canada and the U.K., plans to take a broader view of the potential anti-competitive effects to drug company acquisitions

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Stanford researchers use AI to empower environmental regulators

Scienmag

Credit: Nina Brooks Like superheroes capable of seeing through obstacles, environmental regulators may soon wield the power of all-seeing eyes that can identify violators anywhere at any time, according to a new Stanford University-led study.

UK drug regulator is first to clear Pfizer, BioNTech's coronavirus vaccine

Bio Pharma Dive

The approval is a notable milestone in the historic pursuit of a protective shot for COVID-19. The two drugmakers plan to ship the first doses within days

#news #biotech DNA methylation regulator QSER1 identified

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: DNA methylation regulator QSER1 identified.A has identified a DNA methylation regulator called QSER1. team of researchers from a number of institutions in the U.S. In their paper … Continue reading → #news

EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

Pharma Phorum

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. News Patients AstraZeneca ema regulation safety

EU regulator endorses Celltrion monoclonal antibody as COVID-19 treatment

BioPharma Reporter

Markets & RegulationsThe European Medicines Agency (EMA) concludes that Celltrionâs monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.

IBA – Regulated Information

BioTech 365

October 05, 2020, 17h45 Publication made under article 15 of the law of May 2, 2007 relating to the disclosure of major holdings in issuers whose shares are admitted to trading on a regulated market and containing various provisions (Belgian … Continue reading → GlobeNewswire

Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner ?

XTalks

It does, however, regulate toxins in other consumer products including arsenic, lead and cadmium, and the agency previously declared them dangerous to human health, particularly to babies and children.

Brainstem Neurons Identified as Regulator of Inflammation

BioTech 365

Brainstem Neurons Identified as Regulator of Inflammation Brainstem Neurons Identified as Regulator of Inflammation Feinstein Institutes’ researchers publish in PNAS new avenue of bioelectronic nerve stimulation to control human body inflammation MANHASSET, N.Y.–(BUSINESS

MHRA publishes guidance on medicine regulation after Brexit

Pharma Phorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. The post MHRA publishes guidance on medicine regulation after Brexit appeared first on.

IBA – Regulated information – Erratum

BioTech 365

October 12, 2020, 17h45 Please consult the erratum of the press release of October 5, 2020 attached and disregard the previous one. The change is at the level of the shareholder graph. Publication made under article 15 of the law … Continue reading → GlobeNewswire

Regulating the ribosomal RNA production line

Scienmag

Cryo-electron microscopy study allows researchers to visualize structural changes in an E.

RNA 56

Regulators questioned integrity of Pfizer/BioNTech vaccine, leaked files show

Pharma Phorum

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack.

Immune Regulation's Rebrand Reflects 'Revolutionary' Approach to Autoimmune Diseases

BioSpace

New Orleans-based Revolo Biotherapeutics, formerly known as Immune Regulation, rebranded to reflect its revolutionary scientific approach to dramatically alter the autoimmune and allergic disease treatment landscape

Selective mRNA degradation via autophagy: A novel role for autophagy in gene regulation

Scienmag

Credit: Tokyo Tech Optimal cell function requires a fine balance between the synthesis and degradation of biomolecules.

EU regulators approve Novartis' breast cancer combo

Pharma Times

Piqray in combination with fulvestrant is the first treatment for tumours with a PIK3CA mutation

Vanilla cultivation under trees promotes pest regulation

Scienmag

Research team led by University of Göttingen investigates agroforestry systems in Madagascar Credit: Annemarie Wurz The cultivation of vanilla in Madagascar provides a good income for small-holder farmers, but without trees and bushes the plantations can lack biodiversity.

European regulators begin rolling review of AZ’s COVID-19 vaccine

Pharma Phorum

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

E.U. Regulator Argues to Continue J&J Vaccine With a Warning Label

NY Times

The European Union’s drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.

Newly discovered mechanism regulates myocardial distensibility

Scienmag

Team of researchers studies how oxidative stress influences the elasticity of the heart muscle Credit: Linke Lab A healthy heart beats 50 to 100 times a minute and pumps 8,000 litres of blood around our body every day.

Why intelligent automation is the future for regulation

Pharma Phorum

The post Why intelligent automation is the future for regulation appeared first on. Digital Market Access Views & Analysis Views and analysis Accenture automation regulation

With 70% Efficacy, AstraZeneca-Oxford COVID-19 Vaccine Heads to Regulators

BioSpace

AstraZeneca and the University of Oxford published an interim analysis of their four Phase III clinical trials of AZD1222, their COVID-19 vaccine

Pressure-regulated excitonic feature enhances photocurrent of all-inorganic 2D perovski

Scienmag

Credit: Xujie Lü HPSTAR scientists Dr. Songhao Guo and Dr. Xujie Lü report three orders of magnitude increase in the photoconductivity of Cs2PbI2Cl2 from its initial value, at the industrially achievable level of 2 GPa, using pressure regulation.

On exclusion of shares from the regulated market

BioTech 365

On exclusion of shares from the regulated market On exclusion of shares from the regulated market On exclusion of shares from the regulated market JSC “Grindeks” hereby informs that according to the decision of the unscheduled General Meeting of JSC … Continue reading → GlobeNewswire

EU regulators ‘worried’ member states undermined AZ vaccine

Pharma Phorum

European regulators are “worried” that national regulators may have undermined trust in the Oxford University/AstraZeneca vaccine by temporarily suspending its use, despite central guidance to keep using it until a safety review has concluded later this week. .

#news #biotech Two genes regulate social dominance

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Two genes regulate social dominance.Rank in social hierarchy is a condition not solely claimed by humans. In the animal kingdom, male peacocks exhibit brightly colored plumes to … Continue reading → #news

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine

The Pharma Data

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. Professional. FRIDAY, Jan.

Moderna Works With International Regulators to Speed Up COVID-19 Vaccine Review Process

BioSpace

Moderna is working with international regulators to accelerate approval of the company’s COVID-19 vaccine candidate, mRNA-1273

Vitamin D regulates calcium in intestine differently than previously thought

Scienmag

Rutgers study could help better treat calcium malabsorption due to bariatric surgery and aging A Rutgers study has discovered that vitamin D regulates calcium in a section of the intestine that previously was thought not to have played a key role.

INNCO Calls for Sensible Regulation of Nicotine Alternatives in Vietnam

BioTech 365

INNCO Calls for Sensible Regulation of Nicotine Alternatives in Vietnam INNCO Calls for Sensible Regulation of Nicotine Alternatives in Vietnam Global Advocacy Organisation Stresses Need for Consumer Access to Tobacco Harm Reduction Products HANOI, Vietnam, Jan.

#news #biotech Transporter protein regulates root gravitropism in Arabidopsis

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Transporter protein regulates root gravitropism in Arabidopsis.In a finding that could be used to improve the nutrient uptake of crops, a RIKEN-led team has identified a transporter … Continue reading → #news

Regulating sanitation services as a public good

The Pharma Data

Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes.

Study Identifies New Role of BioAegis’ ‘Inflammation Regulator’ Gelsolin Relevant for a Range of Inflammatory Diseases

BioTech 365

Study Identifies New Role of BioAegis’ ‘Inflammation Regulator’ Gelsolin Relevant for a Range of Inflammatory Diseases Study Identifies New Role of BioAegis’ ‘Inflammation Regulator’ Gelsolin Relevant for a Range of Inflammatory Diseases Gelsolin mitigates vascular damage by preventing release of … Continue reading → GlobeNewswire

EU regulators begin fast review of dexamethasone for COVID-19

Pharma Phorum

European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a potentially cheaper option to aid recovery than Gilead’s Veklury. The post EU regulators begin fast review of dexamethasone for COVID-19 appeared first on.

US Regulators Recommend Pause on J&J’s COVID-19 Vaccine, But Just as a Precaution

XTalks

Federal authorities in the US have recommended pausing the administration of J&J’s COVID-19 vaccine as half a dozen cases of rare blood clots reported among women who received the vaccine are under investigation. One of the cases was fatal.

Medical Marijuana Is Not Regulated as Most Medicines Are

NY Times

The industry lacks randomized controlled clinical trials that can clearly establish benefits and risks. Medical Marijuana Marijuana Cannabis Foods and Products Drug Abuse and Traffic Drugs (Pharmaceuticals) Glaucoma Multiple Sclerosis

Hackers posted stolen COVID-19 vaccine info online, says EU regulator

Pharma Phorum

The post Hackers posted stolen COVID-19 vaccine info online, says EU regulator appeared first on. Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update.

EU regulators to review Evrysdi for SMA

Pharma Times

The decision triggers a £15m milestone payment from Roche to PTC Therapeutics

#news #biotech Study uncovers structural features regulating mRNA processing

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Study uncovers structural features regulating mRNA processing.RNA is the central tenet of molecular biology, the stepping-stone between DNA and proteins.

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Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

XTalks

Although PFAS-containing products appear to impact the same biological receptor or mechanisms in the body as those that were banned, the FDA does not regulate the entire class of PFAS chemicals, but rather one specific chemical at a time.

Are you ready for the new European clinical trial regulation?

CATO Research

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive , the directive that currently describes how clinical trials should be conducted in Europe. The regulation will have a major impact on the conduct of clinical trials.

New blueprint of brain connections reveals extensive reach of central regulator

Scienmag

Map of basal ganglia connectivity uncovers key links with implications for range of disorders Credit: Lauren McElvain / Kleinfeld lab / UC San Diego) Thousands of our daily activities, from making coffee to taking a walk to saying hello to a neighbor, are made possible through an ancient collection of brain structures tucked away near […].