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 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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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

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 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.

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

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

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

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

Hallmark cancer gene regulates RNA ‘dark matter’


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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Study identifies key regulator of cell differentiation


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.

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

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

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

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.

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


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

'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

New method boosts the study of regulation of gene activity


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.

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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

AstraZeneca's COVID drug Evusheld is trending up with a go-ahead from regulators in Europe

Fierce Pharma

AstraZeneca's COVID drug Evusheld is trending up with a go-ahead from regulators in Europe. kdunleavy. Fri, 09/16/2022 - 10:05

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

Top Food Industry Regulations to Watch in 2022


New regulations are often reflective of the supply chain, food safety and consumer trends. Here are some of the top food industry regulations food and beverage companies should watch out for in 2022. Regulating Heavy Metals in Baby Food. Cannabinoid Regulations.

Electricity regulation with equity and justice for all


Social & Behavioral Science electricity equity Justice regulation

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

A newly identified stem cell regulator enables lifelong sperm production


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, […].

McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators

NY Times

McKinsey & Co Conflicts of Interest Purdue Pharma Food and Drug Administration Opioids and Opiates Regulation and Deregulation of Industry Drugs (Pharmaceuticals) Azar, Alex M IIThe firm let consultants advise both drugmakers and their government overseers, internal records show.

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.

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.

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


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

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


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

Researchers identify key regulators of urinary concentration in the kidney


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 […].

HKUST-led research reveals a novel molecular mechanism that regulates secretion of sonic hedgehog, shedding light on cancer treatments


Cancer cancer hedgehog HKUSTled light mechanism molecular regulates research reveals secretion Shedding Sonic treatments

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

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


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.

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.

Methylation of tRNA-derived fragments regulates gene-silencing activity in bladder cancer


and colleagues have described a novel form of gene regulation that is altered in bladder cancer, leading to the boosting of a gene pathway that helps the cancer cells survive during rapid growth. Biology activity bladder cancer fragments genesilencing methylation regulates tRNAderived

Yale researchers have uncovered a regulator of body weight that could lead to new treatments for metabolic disorders


Yale scientists uncover key regulator of body weight. Yale scientists have discovered that a protein known as augmentor-alpha regulates body weight in mice, an insight that could lead to new treatments for metabolic disorders. New Haven, Conn.

The mechanisms regulating the balance between the formation of neurons and the maintenance of stem cells in the formation of the brain revealed


Anew study by the Neuronal Dynamics Research Group at UPF has elucidated the cellular and molecular mechanisms that regulate the balance between the differentiation of neurons and the maintenance of progenitor cells during the construction of the embryonic brain.

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 "

New insights into how cyanobacteria regulate zinc uptake in the open ocean


However, little is known about whether and how cyanobacteria utilize or regulate zinc, […]. Latest News cyanobacteria insights ocean open regulate uptake zinc Marine cyanobacteria are major contributors to the global carbon cycle and are the basis of the food web in many of the world’s oceans. They only require sunlight, carbon dioxide, plus a panel of essential elements, including metals, to sustain life.

GSK Headed to Regulators with RSV Vaccine


GSK reported positive headline data from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine

Researchers identify key regulator of blood stem cell development


Latest News blood cell development identify key Regulator researchers StemA protein that masterminds the way DNA is wrapped within chromosomes has a major role in the healthy functioning of blood stem cells, which produce all blood cells in the body, according to a new study from researchers at Weill Cornell Medicine. The protein, known as histone H3.3, organizes the spool-like structures around which DNA […].

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