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.

Drugs 52

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

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

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

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.

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

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

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 58

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

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

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

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

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.

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

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

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

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 […].

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

Electricity regulation with equity and justice for all

Scienmag

Social & Behavioral Science electricity equity Justice regulation

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

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

Scienmag

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

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

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

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

Scienmag

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.

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

Scienmag

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.

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

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

Scienmag

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

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

Scienmag

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.

GSK Headed to Regulators with RSV Vaccine

BioSpace

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

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.

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.

Researchers identify key regulator of blood stem cell development

Scienmag

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 […].

Research Roundup: Gene Regulation and Longevity, Comparing COVID-19 Vaccines

BioSpace

Top research stories, including gene regulation and longevity, a head-to-head comparison of COVID-19 vaccines, a newly discovered type of brain cell and more

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

Scienmag

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.

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.

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

Scienmag

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

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 "

Argentina CBD and Cannabis Market Regulations Report 2022 – ResearchAndMarkets.com

BioTech 365

Argentina CBD and Cannabis Market Regulations Report 2022 – ResearchAndMarkets.com Argentina CBD and Cannabis Market Regulations Report 2022 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Argentina: CBD and Cannabis Regulation” report has been added to ResearchAndMarkets.com’s offering.

Paraguay CBD and Cannabis Markets Regulation Report 2022 – ResearchAndMarkets.com

BioTech 365

Paraguay CBD and Cannabis Markets Regulation Report 2022 – ResearchAndMarkets.com Paraguay CBD and Cannabis Markets Regulation Report 2022 – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “Paraguay: CBD and Cannabis Regulation” report has been added to ResearchAndMarkets.com’s offering.

Epigenetic regulator explains why some lung cancer patients become resistant to common therapeutics

Scienmag

Latest News cancer common epigenetic explains lung Patients Regulator resistant therapeuticsKey research finding Doctors typically treat people with nonsmall cell lung cancer, a prevalent and typically incurable type of cancer that makes up 80%-85% of lung cancers, with tyrosine kinase inhibitors, specifically epidermal growth factor receptor inhibitors. About 15%-20% of these patients will become resistant to these standard treatments, resulting in their eventual death.

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.

Four things you need to know about FDA regulations and digital health

Pharma Phorum

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. Regulation is regulation, after all. 4.FDA’s digital health regulation can be hard to parse, even for experts.

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