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Noxopharm cancer drug secures Orphan Drug Designation from FDA

Outsourcing Pharma

Markets & RegulationsThe Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.

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European regulators back hemophilia gene therapy

Bio Pharma Dive

The EMA’s drug review committee recommended five new drugs be approved in Europe during its December meeting, including CSL’s Hemgenix, AstraZeneca’s Imjudo and Amicus’ Pombiliti

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More federal regulators investigating Biogen's Alzheimer's drug

Bio Pharma Dive

In a regulatory filing, Biogen said the FTC and the SEC are looking for information about Aduhelm's approval and marketing, meaning the drug is now the focus of four government probes

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European regulator recommends Bavarian Nordic's vaccine for monkeypox

Bio Pharma Dive

The positive decision comes as governments aim to expand supply and quicken distribution of the vaccine to combat a widening global outbreak. Separately, the EMA backed approvals of 11 other medicines

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The drug industry continues to dare regulation

World of DTC Marketing

The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. Pfizer expects to make as much as $22bn from its new Covid pill this year, on top of $37bn it made in 2021 from the vaccine.

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PTC's first gene therapy gains European regulator's backing

Bio Pharma Dive

The brain-infused treatment for a rare neurological disease would be one of only three gene therapies commercially available in the EU. PTC plans to ask for FDA approval later this year

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2022 in review: Regulation starts to catch up with AI in pharma

Pharmaceutical Technology

But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances. The post 2022 in review: Regulation starts to catch up with AI in pharma appeared first on Pharmaceutical Technology.

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An arising roadmap to regulating sanitation services

The Pharma Data

An arising roadmap to regulating sanitation services. MoEP, Serbia), Alyse Schrecongost( BMGF) Upon the launch of the State of the World’s Sanitation report in 2020, WHO along with UNICEF, ESAWAS and BMGF participated a blog entitled “ Regulating sanitation services as a public good ”.

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EMA backs restrictions on certain immune-regulating drugs

Bio Pharma Dive

Once the European Commission signs off, use of several so-called JAK inhibitors sold by Eli Lilly, Pfizer and other drugmakers will be limited among smokers and patients who are at high risk of certain health complications

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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

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EMA looks to follow the FDA in limiting use of certain immune-regulating drugs

Bio Pharma Dive

The new recommendations could further curtail the use of so-called JAK inhibitors, though the restrictions imposed in Europe are less severe than they are in the U.S.

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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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Are drug regulators sufficiently independent from the companies they are meant to regulate?

Scienmag

Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of new medicines before they hit the market. But an investigation published by The BMJ today finds that industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals. Latest News companies Drug independent meant regulate regulators sufficiently

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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

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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

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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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Study identifies key regulator of cell differentiation

Scienmag

Biology cell differentiation identifies key Regulator studyCHAMPAIGN, Ill. Embryonic stem cells and other pluripotent cells divide rapidly and have the capacity to become nearly any cell type in the body.

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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

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Here’s Why the USDA Updated its Organic Food Regulations

XTalks

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. The new rule, which will come into effect on March 20th, is the biggest change to the USDA’s organic food regulations since they were first adopted in 1990.

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Hallmark cancer gene regulates RNA ‘dark matter’

Scienmag

Cancer cancer dark gene Hallmark matter regulates RNAA key genetic mutation that occurs early on in cancer alters RNA “dark matter” and causes the release of previously unknown RNA biomarkers for cancer early detection, a new study by UC Santa Cruz researchers published in the journal Cell Reports shows. Credit: Daniel H. Kim A key genetic mutation that occurs early on in […].

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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

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Sex differences emerging in blood pressure regulation

Scienmag

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.

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'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

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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

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EU regulator says member countries can use Pfizer's experimental COVID pill

Bio Pharma Dive

The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use

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Electricity regulation with equity and justice for all

Scienmag

Social & Behavioral Science electricity equity Justice regulation

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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

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Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

The FDA Law Blog

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. By Jeffrey N. Gibbs & Sara W.

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The zinc link: Unraveling the mechanism of methionine-mediated pluripotency regulation

Scienmag

Differentiation of pluripotent stem cells (PSCs) is regulated through a methionine-mediated mechanism, which has now been pinpointed by Tokyo Tech researchers. Chemistry AND Physics Link mechanism methioninemediated pluripotency regulation Unraveling zinc

Insulin 76
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New method boosts the study of regulation of gene activity

Scienmag

Researchers have found that in bacteria DNA methylation plays a role in regulating virulence, reproduction and gene […]. Latest News activity boosts gene method regulation studyOne way cells can control the activities of their genes is by adding small chemical modifications to the DNA that determine which genes are turned on or off. Methyl groups are one of these chemical modifications or tags.

DNA 55
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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.

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How competitors are collaborating to shape biopharma best practices and regulations of the future

Pharmaceutical Technology

The collaborative spirit arising between pharmaceutical and biotechnology companies is leading to a new rapport with regulators, as well. There aren’t any regulations or guidance to really satisfy what we’re trying to do.

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EU regulators issue guidance on decentralised trials

Pharma Phorum

In a statement, the regulators note that the aim of DCTs – enabled by digital tools, telemedicine and more mobile and local healthcare – is to make it easier for patients to participate in clinical trials by reducing the need to travel to central trial sites.

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University of Warwick proposes new quality and safety regulations report for micromobility vehicles

Scienmag

The University of Warwick wants to change that and has proposed a new set of regulations for allowing micromobility vehicles, such as e-scooters to operate legally in the UK. Atmospheric Science micromobility proposes quality regulations Report safety University Vehicles Warwick

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A newly identified stem cell regulator enables lifelong sperm production

Scienmag

Latest News cell enables identified lifelong Newly production Regulator sperm StemUnlike women, who are born with all the eggs they’ll ever have, men can continue to produce sperm throughout their adult lives. To do so, they require a constant renewal of spermatogonial stem cells, which give rise to sperm. This reinvigoration of stem cells depends on a newly characterized stem cell self-renewal factor called DOT1L, […].

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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

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Researchers identify key regulators of urinary concentration in the kidney

Scienmag

BOSTON — Proper function of the kidney is critical for concentrating urine, regulating blood pressure, and for the tight control of electrolyte levels in the blood. Latest News Concentration identify key kidney regulators researchers UrinaryThe kidney achieves these important functions through many microscopic functional units, called nephrons. These nephrons consist of different segments with distinct functions. How these segments form during development and […].

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Roche, having shared data with regulators, unwraps results of subcutaneous Tecentriq phase 3 trial

Fierce Pharma

Roche, having shared data with regulators, unwraps results of subcutaneous Tecentriq phase 3 trial. ntaylor. Thu, 12/01/2022 - 09:45

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UK regulators warn of ocular side effects after treatment with Sanofi's Dupixent

Fierce Pharma

UK regulators warn of ocular side effects after treatment with Sanofi's Dupixent. zbecker. Wed, 11/30/2022 - 10:55

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Will Modernization of Cosmetic Regulation Finally Happen?

FDA Law Blog

Specifically, FDASLA includes the Modernization of Cosmetics Regulation Act of 2022 proposing significant amendments to the FDC Act, intended to modernize safety standards for cosmetics in the United States.

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Dopamine regulates insulin secretion through a complex of receptors, finds new study

Scienmag

Research has shown that the feel-good hormone, dopamine (DA), plays a key role in how the body regulates the production of insulin. Biology complex Dopamine finds insulin receptors regulates secretion study

Insulin 65
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Cancer microRNA may play a role in regulating events in the nucleus

Scienmag

microRNAs (miRNA), non-coding RNA molecules, are widely known for regulating mRNA stability and translation. Latest News cancer events microRNA nucleus play regulating rolemiR-10b has been increasingly implicated in the pathogenesis of gliomas, cancers of the brain.

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Wellcome funds work on regulating digital mental health tools

Pharma Phorum

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on.