Bluebird's next gene therapy gets backing from European regulator

Bio Pharma Dive

The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world

AstraZeneca deal for Alexion to close soon as UK regulator clears acquisition

Bio Pharma Dive

The go-ahead from British regulators was the last hurdle standing in the way of the two companies wrapping up their $39 billion deal announced last year

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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

With safety worries mounting, FDA limits who can take certain immune-regulating drugs

Bio Pharma Dive

The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors

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

Third Rock launches biotech targeting 'notoriously difficult' DNA regulators

Bio Pharma Dive

With $82 million in hand, Flare Therapeutics is looking to create precision cancer drugs by going after a type of protein called transcription factors

'The lights are no longer green': Antitrust regulators reassess pharma deals

Bio Pharma Dive

The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next

European regulators push 8 drugs toward approval, including controversial anemia pill

Bio Pharma Dive

A key committee of the EMA gave a positive review of Astellas and Fibrogen's roxadustat, as well as Bristol Myers Squibb's cell therapy Abecma and UCB's psoriasis drug Bimzelx

Researchers shed new light on mechanical regulation of epithelial tissue homeostasis

Scienmag

Chemistry AND Physics epithelial homeostasis light Mechanical regulation researchers shed tissueAn international team of scientists, led by Professor Ana-Sun?ane ane Smith from the Croatian Ru?er er Boškovi?

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

Global regulators seek permanent working group on AI

Pharma Phorum

The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments.

UK regulator reviews AstraZeneca’s Alexion acquisition

BioPharma Reporter

Markets & RegulationsThe UKâs Competition and Markets Authority (CMA) is inviting comments on AstraZenecaâs $39bn acquisition of Alexion.

Researchers speed identification of DNA regions that regulate gene expression

Scienmag

Jude Children’s Research Hospital scientists have developed a highly efficient method to address a major challenge in biology–identifying the genetic ‘switches’ that regulate gene expression.

Regulating the ribosomal RNA production line

Scienmag

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

RNA 83

Fast track for variant-specific COVID-19 vaccines, say ACCESS regulators

BioPharma Reporter

A coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland has set out guidance for how variant-specific versions of authorized vaccines will be regulated: saying they will not need brand new approval or lengthy clinical studies. Markets & Regulations

FDA UDI vs. EU MDR Regulations Consideration of the Regulations and Implications for EU Labelling

Journal for Clinical Studies

In the EU, the new EU MDR regulation came into force in May 2017 (2017/745) and will replace the current… The post FDA UDI vs. EU MDR Regulations Consideration of the Regulations and Implications for EU Labelling appeared first on Journal for Clinical Studies.

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

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

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.

EU, US regulators apply similar mindset when advising live biotherapeutic product developer

Scienmag

Chemistry AND Physics advising apply biotherapeutic developer live mindset product regulators similar

MyMD Pharma Develops Low-Toxicity, Plant-Based TNF-? Regulator

BioSpace

regulator may be able to be commercialized without the black-box warnings that accompany so many TNF-? MyMD Pharmaceuticals’ TNF-? therapies

Trelleborg helps wearables firms navigate new EU regulation

Outsourcing Pharma

The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week. Markets & Regulations

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

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.

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.

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

To prevent next pandemic, scientists say we must regulate air like food and water

Scienmag

Credit: Martin Visser, Unsplash Humans in the 21st century spend most of their time indoors, but the air we breathe inside buildings is not regulated to the same degree as the food we eat and the water we drink.

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

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.

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

Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators

BioTech 365

Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators Underdog Pharmaceuticals Awarded ‘Innovation Passport’ by UK Regulators MOUNTAIN VIEW, Calif., 08, 2021 (GLOBE NEWSWIRE) — Underdog Pharmaceuticals, Inc. Underdog), a pre-clinical stage pharmaceutical company focusing on the treatment and reversal … Continue reading → GlobeNewswire

EU Clinical Trial Regulation: What, When, Who, Why, How?

CATO Research

The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review process for clinical trials via a centralized portal, is finally knocking at our doors.

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.

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.

#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 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.

#news #biotech Rooting regulators are evolutionarily conserved

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Rooting regulators are evolutionarily conserved.Many plants can easily be regenerated and multiplied using cuttings. Crucial is that the cutting can initiate the formation of roots, a process … Continue reading → #news

Predicting the Future of Data Privacy Regulation

Intouch Solutions

The post Predicting the Future of Data Privacy Regulation appeared first on Intouch Solutions. Get our summary of a discussion between the Coalition for Healthcare Communication and Alison Pepper, EVP of Government Relations at the 4A's, about the current data-privacy landscape.

EU regulators approve Novartis' breast cancer combo

Pharma Times

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

Apoptosis Regulator BAX Drugs Development Market Research Report 2021 – ResearchAndMarkets.com

BioTech 365

Apoptosis Regulator BAX Drugs Development Market Research Report 2021 – ResearchAndMarkets.com Apoptosis Regulator BAX Drugs Development Market Research Report 2021 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Apoptosis Regulator BAX – Drugs In Development, 2021” drug pipelines has been added to ResearchAndMarkets.com’s offering.

EU safety regulators clear J&J COVID shot despite tiny clot risk

Pharma Phorum

The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. The post EU safety regulators clear J&J COVID shot despite tiny clot risk appeared first on.

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.

UK regulator backs Amarin’s cardiology drug Vazkepa

Pharma Phorum

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The post UK regulator backs Amarin’s cardiology drug Vazkepa appeared first on.