Antitrust regulators aim to revamp merger guidelines, signaling threat to health sector deals

Bio Pharma Dive

The news sparked headlines about an attempt by regulators to target big tech, but it could have serious implications for healthcare, too

European drugs regulator signals rejection likely for Biogen's Aduhelm

Bio Pharma Dive

A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month


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Incyte withdraws cancer drug from FDA review after discussions with regulator

Bio Pharma Dive

The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals

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

Electricity regulation with equity and justice for all


Social & Behavioral Science electricity equity Justice regulation

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

Sex differences emerging in blood pressure regulation


Biology blood differences emerging pressure regulation sexAUGUSTA, Ga. 18, 2021) – Another difference between females and males appears to be a key mechanism in how they become hypertensive, scientists say, and consequently which antihypertensives should be most effective for them.

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

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

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

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

'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

Salk researchers find a new route for regulating blood sugar levels independent of insulin


Biology blood find independent insulin levels regulating researchers route Salk sugarLA JOLLA—(January 4, 2022) The discovery of insulin 100 years ago opened a door that would lead to life and hope for millions of people with diabetes.

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

Leonhardt Ventures Files Patent for Bioelectric Diabetes Reversal Treatment via FABp4 Regulation and Klotho Regulation

BioTech 365

Leonhardt Ventures Files Patent for Bioelectric Diabetes Reversal Treatment via FABp4 Regulation and Klotho Regulation Leonhardt Ventures Files Patent for Bioelectric Diabetes Reversal Treatment via FABp4 Regulation and Klotho Regulation Mission Viejo, California, United States, Dec.

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Food and Drug Regulations , C.R.C., Medical Devices Regulations , SOR/98-282.

New commentary offers reforms to regulations that hindered Seattle flu study surveillance of SARS-CoV-2


SEATTLE (January 10, 2022) – As the two-year anniversary of the pandemic approaches, a new commentary provides insights into reforming the “labyrinth of conflicting and uncoordinated actions among state and federal regulators” that in early 2020 hampered Seattle researchers from community testing for COVID-19. Latest News Commentary flu hindered offers reforms regulations SARSCoV2 Seattle study surveillance

European regulators say no to Aduhelm, but Biogen is pushing back

Bio Pharma Dive

The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks "

Clinical trials: 2021 Recap and take-aways for 2022 and ahead. From Vaccine trials, new regulations, decentralized trials and patient-centricity


From Vaccine trials, new regulations, decentralized trials and patient-centricity appeared first on Clinical Trial Recruitment & Management Services. Blog clinical trial patient recruitment decentralized trials hybrid trials patient centricity regulation changes

Immune cell receptor and ligand regulation: A therapeutic avenue for inflammatory diseases


Medicine & Health avenue cell diseases immune inflammatory ligand receptor regulation therapeuticImmune cells play a key role in mediating inflammatory responses.

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

Regulation optimisation could save thousands of life years

Pharma Phorum

The post Regulation optimisation could save thousands of life years appeared first on. Market Access Oncology Patients Views & Analysis Views and analysis cancer digital regulation

Researchers shed new light on mechanical regulation of epithelial tissue homeostasis


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?

Regulating the ribosomal RNA production line


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

RNA 83

Post-Brexit medicines regulation must have international scope

Pharma Phorum

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As

Researchers speed identification of DNA regions that regulate gene expression


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.

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.

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.

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.

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


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.

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.

Researchers discover new mechanism that regulates the spread of breast cancer


Cancer breast cancer discover mechanism regulates researchers spreadResearchers have known for decades that human cells migrate by circulating cell surface adhesion receptors from one part of the cell to another.

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

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

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.

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

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

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

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


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

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


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.