Regulation - Clinical Research Informer

UK MHRA strengthens regulations on fluoroquinolone antibiotics

Pharmaceutical Technology

JANUARY 23, 2024

The UK MHRA has introduced further restrictions on the usage of fluoroquinolone antibiotics, strengthening the previous regulations.

Regulation

Europe's drug regulator links J&J's vaccine to rare clots as US pause continues

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.

Regulation

Regulation Vaccination Vaccine Drugs

Islet transplantation for type 1 diabetes: Do regulators have it right?

Pharmaceutical Technology

OCTOBER 9, 2023

Diabetes researchers oppose the regulation of islet transplantation as a biologic, following the approval of CellTrans’ Lantidra.

Regulation

Regulation Research

European regulator recommends Bavarian Nordic's vaccine for monkeypox

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.

Regulation

Regulation Vaccination Vaccine Medicine

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

PCI frames new regulations based on amendments under Jan Vishwas Act

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

The Pharmacy Council of India (PCI) has framed regulations on the manner of conducting enquiry imposing penalty and appeal procedures in case of violation of certain provisions of the Pharmacy Act, 1948, in tune with the amendments notified in the Jan Vishwas (Amendment of Provisions) Act, 2023.

Regulation

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European regulators back hemophilia gene therapy

Bio Pharma Dive

DECEMBER 16, 2022

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.

Gene Therapy

Gene Therapy Regulation Gene Drugs

Eisai wins over European regulators on Alzheimer’s drug Leqembi

Bio Pharma Dive

NOVEMBER 14, 2024

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

Regulation

Regulation Drugs Marketing

Bluebird's next gene therapy gets backing from European regulator

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.

Gene Therapy

Gene Therapy Gene Regulation Production

More federal regulators investigating Biogen's Alzheimer's drug

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.

Regulation

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European drugs regulator signals rejection likely for Biogen's Aduhelm

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

Regulation

Regulation Drugs Medicine

'The lights are no longer green': Antitrust regulators reassess pharma deals

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.

Regulation

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

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.

Gene Therapy

Gene Therapy Gene Regulation FDA Approval

CDSCO empowers regulators & boosts exports through comprehensive training programmes

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2024

With a focus on equipping regulators with advanced skills, the CDSCO conducted 23 residential training programmes tailored to address critical aspects such as […]

Regulation

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As drug shortages reach record highs, regulators weigh next steps

Bio Pharma Dive

MAY 6, 2024

With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.

Regulation

Regulation Drugs

European regulators push 8 drugs toward approval, including controversial anemia pill

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.

Regulation

Regulation Drugs

Health ministry issues draft rules for compounding of certain offences under drug regulations

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 21, 2024

The Union health ministry has issued a draft notification framing the rules related to compounding of offences for minor offences under the drug regulations.

Regulation

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European regulators probe suicide risk to Ozempic, other Novo drug Saxenda

Bio Pharma Dive

JULY 10, 2023

Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.

Regulation

Regulation Drugs

IRA lawsuits will test US’ ability to regulate social pricing in pharma

Pharmaceutical Technology

JANUARY 16, 2024

As the deadline nears for the government to reveal its proposed prices, pharmaceutical companies are continuing to fight regulation.

Regulation

With safety worries mounting, FDA limits who can take certain immune-regulating drugs

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.

Regulation

Regulation Drugs

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

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.

Regulation

Regulation Medicine

European regulators want to know more about the risks of GLP-1 drugs

Bio Pharma Dive

DECEMBER 1, 2023

The EMA's safety committee has more questions for makers of the in-demand therapies as it reviews whether the drugs are linked to the risk of suicidal thoughts.

Regulation

Regulation Drugs

Leqembi voted down by European regulators

Bio Pharma Dive

JULY 26, 2024

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

Regulation

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

Bio Pharma Dive

OCTOBER 28, 2022

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.

Regulation

Regulation Drugs

European regulator concludes no suicide link to obesity drugs

Bio Pharma Dive

APRIL 12, 2024

The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.

Regulation

Regulation Drugs Medicine

At FDA meeting, gene therapy experts wrestle with field's blindspots

Bio Pharma Dive

SEPTEMBER 3, 2021

A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field.

Gene Therapy

Gene Therapy Gene Regulation Research

European regulators push Biogen, CRISPR drugs toward approval

Bio Pharma Dive

DECEMBER 15, 2023

While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclaris, acquired through a recent acquisition, was no sure bet.

Gene Editing

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Bluebird gene therapy approved by FDA for rare blood disease

Bio Pharma Dive

AUGUST 17, 2022

The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.

Gene Therapy

Gene Therapy Gene Regulation Medicine

What to expect at the FDA's two-day meeting on gene therapy safety

Bio Pharma Dive

SEPTEMBER 1, 2021

A group of advisers convened by the regulator will spend Thursday and Friday weighing a range of safety worries with gene therapy, and how best to prevent them.

Gene Therapy

Gene Therapy Gene Regulation

Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

Bio Pharma Dive

JANUARY 10, 2022

A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.

Trials

Trials Regulation

Pharma under the microscope as FTC considers new ways to review acquisitions

Bio Pharma Dive

JUNE 16, 2022

Economists and regulators also appeared worried by the effect of buyouts on innovation. At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration.

Regulation

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FDA advisers back microbiota-based treatment for gut infection

Bio Pharma Dive

SEPTEMBER 23, 2022

diff infections of the intestines, a condition with no regulated options after antibiotics fail. Committee members voted in support of Rebiotix’s treatment for recurrent C.

Regulation

AstraZeneca, Oxford vaccine study allowed to restart in UK

Bio Pharma Dive

SEPTEMBER 12, 2020

study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume. Six days after a worrisome illness in a U.K.

Vaccination

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Pfizer follows GSK with positive Phase 3 results for RSV vaccine

Bio Pharma Dive

AUGUST 25, 2022

In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.

Regulation

Regulation Vaccination Vaccine

Moderna, chasing GSK and Pfizer, brings RSV vaccine to regulators

Bio Pharma Dive

JULY 5, 2023

The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

Vaccination

Vaccination Vaccine Regulation Sales

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

FDA Approval

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BioMarin says gene therapy hold will endure as FDA questions cancer risk

Bio Pharma Dive

FEBRUARY 18, 2022

According to BioMarin, the regulator has requested additional data to assess the "theoretical" cancer risk to the treatment, information that will take "several quarters" to collect.

Gene Therapy

Gene Therapy Gene Regulation

5 takeaways from the FDA's closely watched coronavirus vaccine meeting

Bio Pharma Dive

OCTOBER 24, 2020

Experts convened by the regulators debated how much data would warrant an approval, while pressing government officials on their distribution plans.

Regulation

Regulation Vaccination Vaccine

Biogen, UCB get the lupus data they’ve waited two decades for

Bio Pharma Dive

SEPTEMBER 23, 2024

The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.

Regulation

Regulation Drugs

FDA clears Rocket to resume testing gene therapy for a rare heart disease

Bio Pharma Dive

AUGUST 16, 2021

The decision from the regulator ends a three-month study pause that had stalled Rocket's development of of the Danon disease treatment.

Gene Therapy

Gene Therapy Gene Regulation Development

Vaccine from Medicago, GSK protective against COVID-19 in large study

Bio Pharma Dive

DECEMBER 7, 2021

The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited.

Vaccination

Vaccination Vaccine Regulation

Psychedelic clinical trials: What sponsors should know when designing new protocols

Bio Pharma Dive

AUGUST 29, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

Clinical Trials

Clinical Trials Clinical Trials Clinical Research Regulation

Vertex, continuing its rebound, cleared to resume testing of diabetes cell therapy

Bio Pharma Dive

JULY 6, 2022

regulators is the latest boost for a company whose shares have climbed more than 30% during the biotech sector’s worst downswing in years. The decision by U.S.

Regulation

In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

MAY 11, 2022

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S.

Gene Editing

Gene Editing Gene Regulation

UK MHRA strengthens regulations on fluoroquinolone antibiotics

Europe's drug regulator links J&J's vaccine to rare clots as US pause continues

Trending Sources

Islet transplantation for type 1 diabetes: Do regulators have it right?

European regulator recommends Bavarian Nordic's vaccine for monkeypox

The New Age of Decentralized Clinical Trials

PCI frames new regulations based on amendments under Jan Vishwas Act

European regulators back hemophilia gene therapy

Eisai wins over European regulators on Alzheimer’s drug Leqembi

Bluebird's next gene therapy gets backing from European regulator

More federal regulators investigating Biogen's Alzheimer's drug

European drugs regulator signals rejection likely for Biogen's Aduhelm

'The lights are no longer green': Antitrust regulators reassess pharma deals

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

CDSCO empowers regulators & boosts exports through comprehensive training programmes

As drug shortages reach record highs, regulators weigh next steps

European regulators push 8 drugs toward approval, including controversial anemia pill

Health ministry issues draft rules for compounding of certain offences under drug regulations

European regulators probe suicide risk to Ozempic, other Novo drug Saxenda

IRA lawsuits will test US’ ability to regulate social pricing in pharma

With safety worries mounting, FDA limits who can take certain immune-regulating drugs

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

European regulators want to know more about the risks of GLP-1 drugs

Leqembi voted down by European regulators

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

European regulator concludes no suicide link to obesity drugs

At FDA meeting, gene therapy experts wrestle with field's blindspots

European regulators push Biogen, CRISPR drugs toward approval

Bluebird gene therapy approved by FDA for rare blood disease

What to expect at the FDA's two-day meeting on gene therapy safety

Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

Pharma under the microscope as FTC considers new ways to review acquisitions

FDA advisers back microbiota-based treatment for gut infection

AstraZeneca, Oxford vaccine study allowed to restart in UK

Pfizer follows GSK with positive Phase 3 results for RSV vaccine

Moderna, chasing GSK and Pfizer, brings RSV vaccine to regulators

AstraZeneca wins first FDA approval for systemic lupus drug in a decade

BioMarin says gene therapy hold will endure as FDA questions cancer risk

5 takeaways from the FDA's closely watched coronavirus vaccine meeting

Biogen, UCB get the lupus data they’ve waited two decades for

FDA clears Rocket to resume testing gene therapy for a rare heart disease

Vaccine from Medicago, GSK protective against COVID-19 in large study

Psychedelic clinical trials: What sponsors should know when designing new protocols

Vertex, continuing its rebound, cleared to resume testing of diabetes cell therapy

In first, Verve gets clearance to test base editing inside the body

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