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Regulation Related Topics 
Outsourcing Pharma
APRIL 4, 2032
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.
Bio Pharma Dive
JULY 22, 2022
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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Bio Pharma Dive
FEBRUARY 4, 2022
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
World of DTC Marketing
FEBRUARY 21, 2022
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.
Bio Pharma Dive
MAY 20, 2022
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
Bio Pharma Dive
NOVEMBER 17, 2021
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
Bio Pharma Dive
MAY 21, 2021
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
Bio Pharma Dive
JULY 14, 2021
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
Bio Pharma Dive
JANUARY 19, 2022
The news sparked headlines about an attempt by regulators to target big tech, but it could have serious implications for healthcare, too
Scienmag
JULY 19, 2022
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 […].
Scienmag
FEBRUARY 21, 2022
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.
Bio Pharma Dive
APRIL 20, 2021
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
Bio Pharma Dive
MARCH 16, 2021
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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Bio Pharma Dive
MAY 13, 2021
With $82 million in hand, Flare Therapeutics is looking to create precision cancer drugs by going after a type of protein called transcription factors
Bio Pharma Dive
JANUARY 26, 2022
The decision is a further sign of regulators' scrutiny of accelerated approvals for cancer therapies, an initiative that's led to several market withdrawals
Scienmag
OCTOBER 17, 2021
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.
Scienmag
JULY 19, 2022
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
Bio Pharma Dive
JUNE 10, 2021
The FTC and its counterparts abroad are rethinking their approach to drugmaker acquisitions. Past scrutiny offers clues where they may look next
Scienmag
JULY 1, 2022
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.
Bio Pharma Dive
SEPTEMBER 1, 2021
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
Fierce Pharma
SEPTEMBER 16, 2022
AstraZeneca's COVID drug Evusheld is trending up with a go-ahead from regulators in Europe. kdunleavy. Fri, 09/16/2022 - 10:05
Bio Pharma Dive
DECEMBER 16, 2021
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
XTalks
SEPTEMBER 12, 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.
Scienmag
JANUARY 14, 2022
Social & Behavioral Science electricity equity Justice regulation
Bio Pharma Dive
JUNE 25, 2021
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
Scienmag
JULY 14, 2022
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, […].
NY Times
APRIL 13, 2022
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.
Pharma in Brief
AUGUST 9, 2021
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.
FDA Law Blog
JULY 7, 2022
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.
Scienmag
MAY 4, 2022
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
Scienmag
JUNE 21, 2022
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
Scienmag
APRIL 25, 2022
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 […].
Scienmag
MAY 7, 2022
Cancer cancer hedgehog HKUSTled light mechanism molecular regulates research reveals secretion Shedding Sonic treatments
Bio Pharma Dive
DECEMBER 2, 2020
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
Scienmag
FEBRUARY 15, 2022
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.
BioTech 365
DECEMBER 30, 2021
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.
Scienmag
MAY 9, 2022
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
Scienmag
APRIL 11, 2022
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.
Scienmag
JUNE 22, 2022
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.
Bio Pharma Dive
DECEMBER 17, 2021
The company plans to ask the European Medicines Agency to reexamine its conclusion that "the benefits of Aduhelm do not outweigh its risks "
Scienmag
JUNE 9, 2022
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.
BioSpace
JUNE 9, 2022
GSK reported positive headline data from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine
Scienmag
JANUARY 28, 2022
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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