Drugs and Regulation - Clinical Research Informer

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

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

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

Regulation Drugs Marketing

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

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

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

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

SEC recommends approval for MSN Laboratories’ sleep disorder drug

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 14, 2024

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.

Drugs

Drugs Clinical Trials Clinical Trials Branding

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

The drug industry continues to dare regulation

World of DTC Marketing

FEBRUARY 21, 2022

Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply. Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Reportedly, the cost of production for molnupiravir stands at about $17.74.

Regulation

Regulation Drugs Bioequivalency Vaccination

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

Regulation Cosmetics Drugs Clinical Trials

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

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

FDA Approval Clinical Trials Clinical Trials Drugs

Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

OCTOBER 22, 2020

regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness.

FDA Approval

FDA Approval Drugs Regulation

Biogen's closely watched ALS drug comes up short in late-stage study

Bio Pharma Dive

OCTOBER 18, 2021

Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.

Drugs

Drugs 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

UK drug regulator is first to clear Pfizer, BioNTech's coronavirus vaccine

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.

Regulation

Regulation Vaccination Vaccine Drugs

CDSCO empowers regulators & boosts exports through comprehensive training programmes

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2024

In a concerted effort to fortify regulatory capabilities and enhance pharmaceutical exports, the Central Drugs Standard Control Organisation (CDSCO) has orchestrated a series of impactful training initiatives in the fiscal year 2023-24.

Regulation

Regulation Drugs Clinical Trials Clinical Trials

FDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug

Bio Pharma Dive

JULY 26, 2022

Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.

Drugs

Drugs Protein Regulation Research

After setback in the US, Galapagos' main drug finds success elsewhere

Bio Pharma Dive

SEPTEMBER 28, 2020

A month after the FDA surprisingly rejected the rheumatoid arthritis drug, known as filgotinib, and more recently, Jyseleca, it's been cleared by regulators in Europe and Japan.

Drugs

Drugs Regulation

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

New EU trial regulations could expedite approvals and address shortages

Pharmaceutical Technology

FEBRUARY 27, 2025

New EU Clinical Trial Regulations simplify international trials while offering the means to counter drug shortages for trials in Europe.

Regulation

Regulation Trials Clinical Trials Clinical Trials

Relay details new research plans in quest to design better cancer drugs

Bio Pharma Dive

JUNE 27, 2022

The biotech company revealed three new drug candidates for breast cancer, while laying out a path to regulators for its most advanced treatment.

Drugs

Drugs Regulation Research

FDA OKs drugs from Amgen, Argenx, Intra-Cellular in year-end push

Bio Pharma Dive

DECEMBER 20, 2021

The flurry of decisions from the regulator clears for market Amgen and AstraZeneca's asthma treatment Tezspire, Argenx's rare disease drug Vyvgart and Intra-Cellular's Caplyta for bipolar depression.

Drugs

Drugs Regulation Marketing

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

FDA rejects two China-developed cancer drugs

Bio Pharma Dive

MAY 2, 2022

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.

Development

Development Regulation Manufacturing Drugs

Third Rock launches biotech targeting 'notoriously difficult' DNA regulators

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.

DNA

DNA Regulation Protein Drugs

World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

Worldwide Clinical Trials

DECEMBER 19, 2024

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing.

Genetics

Genetics In-Vitro Drugs Clinical Trials

FDA sets decision dates for Vertex, CRISPR gene editing drug

Bio Pharma Dive

JUNE 9, 2023

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

Gene Editing

Gene Editing Gene Regulation Drugs

CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 7, 2024

The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.

Drugs

Drugs Licensing Licensing Regulation

Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

Bio Pharma Dive

SEPTEMBER 17, 2021

Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug. With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline.

Trials

Trials Drugs Regulation

FTC targets ‘junk patents’ on Ozempic, other top drugs

Bio Pharma Dive

MAY 1, 2024

The move broadens the antitrust regulator’s campaign against allegedly “improper or inaccurate” patent listings by drugmakers to include top-selling medicines for weight loss, diabetes, asthma and COPD.

Regulation

Regulation Medicine Drugs

EMA follows FDA in scrutinizing safety of certain immune drugs

Bio Pharma Dive

FEBRUARY 14, 2022

The European regulator began a safety review of so-called Janus kinase inhibitors from Pfizer, AbbVie, Eli Lilly and Galapagos, citing worrisome data from a study of Pfizer's drug Xeljanz.

Drugs

Drugs Regulation

SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

Clinical Trials

Clinical Trials Clinical Trials Drugs Regulation

Europe broadens Lynparza use as FDA ups scrutiny of PARP drugs

Bio Pharma Dive

DECEMBER 21, 2022

regulators delayed a decision on the same indication, a potential sign of the FDA’s concerns around PARP blockers. Lynparza’s authorization in first-line prostate cancer comes days after U.S.

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

Regulation Sales Marketing Drugs

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 again delays review of Amicus rare disease drug

Bio Pharma Dive

OCTOBER 31, 2022

European regulators are also reviewing the treatment and could soon issue an opinion. For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease.

Regulation

Regulation Drugs

EMA expands probe of possible suicide risk to popular weight loss, diabetes drugs

Bio Pharma Dive

JULY 12, 2023

The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.

Drugs

Drugs Regulation Medicine

Pfizer drug acquired in $11B buyout confirms benefit in colon cancer

Bio Pharma Dive

FEBRUARY 3, 2025

regulators to convert Braftovi’s accelerated clearance in colorectal tumors into a full approval — boosting an oncology portfolio Pfizer is looking to for revenue growth. The results could sway U.S.

Regulation

Regulation Drugs

Regeneron says antibody drug may speed recovery of patients with mild COVID-19

Bio Pharma Dive

SEPTEMBER 29, 2020

Preliminary study data suggest the treatment could help people whose bodies aren't already fighting off infection, a finding the biotech is discussing with regulators.

Antibody

Antibody Regulation Drugs

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

Bio Pharma Dive

JUNE 16, 2022

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

Regulation

Regulation Marketing Drugs

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

Vaccination Vaccine Regulation Drugs

Karuna shares soar on schizophrenia drug results

Bio Pharma Dive

AUGUST 8, 2022

The company plans to ask regulators to approve its KarXT therapy based on the results, which one analyst called “as good as one could hope for.”

Regulation

Regulation Drugs

Eisai wins over European regulators on Alzheimer’s drug Leqembi

European drugs regulator signals rejection likely for Biogen's Aduhelm

Trending Sources

More federal regulators investigating Biogen's Alzheimer's drug

As drug shortages reach record highs, regulators weigh next steps

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

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

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

SEC recommends approval for MSN Laboratories’ sleep disorder drug

European regulators back hemophilia gene therapy

The drug industry continues to dare regulation

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

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

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

Gilead's Veklury becomes first FDA-approved drug for COVID-19

Biogen's closely watched ALS drug comes up short in late-stage study

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

UK drug regulator is first to clear Pfizer, BioNTech's coronavirus vaccine

CDSCO empowers regulators & boosts exports through comprehensive training programmes

FDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug

After setback in the US, Galapagos' main drug finds success elsewhere

European regulator concludes no suicide link to obesity drugs

New EU trial regulations could expedite approvals and address shortages

Relay details new research plans in quest to design better cancer drugs

FDA OKs drugs from Amgen, Argenx, Intra-Cellular in year-end push

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

FDA rejects two China-developed cancer drugs

Third Rock launches biotech targeting 'notoriously difficult' DNA regulators

World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

FDA sets decision dates for Vertex, CRISPR gene editing drug

CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

FTC targets ‘junk patents’ on Ozempic, other top drugs

EMA follows FDA in scrutinizing safety of certain immune drugs

SEC recommends approval for Astrazeneca’s anti-hyperkalaemia drug Lokelma in India

Europe broadens Lynparza use as FDA ups scrutiny of PARP drugs

Leqembi voted down by European regulators

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

FDA again delays review of Amicus rare disease drug

EMA expands probe of possible suicide risk to popular weight loss, diabetes drugs

Pfizer drug acquired in $11B buyout confirms benefit in colon cancer

Regeneron says antibody drug may speed recovery of patients with mild COVID-19

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

AstraZeneca, Oxford vaccine study allowed to restart in UK

Karuna shares soar on schizophrenia drug results

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