Marketing and Trials - Clinical Research Informer

Pfizer to pull sickle cell drug from market, shut down trials

Bio Pharma Dive

SEPTEMBER 26, 2024

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.

Trials

Trials Drugs Marketing

Roche, nearing major trial readouts, starts new Alzheimer's drug study

Bio Pharma Dive

MARCH 3, 2022

As Aduhelm sputters on the market, Roche aims to prove its experimental medicine can work better. A large, multi-year trial is part of that bet.

Trials

Trials Medicine Drugs Marketing

BlueRock Advances Bemdaneprocel Cell Therapy to Phase III Trial for Parkinson’s Disease

XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. The clinical advancement follows a thorough review of Phase I trial data under the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation.

Trials

Trials Clinical Trials Clinical Trials Gene Therapy

Is biotech facing a long bear market?

Pharmaceutical Technology

JULY 6, 2022

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7.

Marketing

Marketing Gene Therapy Manufacturing Pharma Companies

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

Pharmaceutical Technology

APRIL 3, 2023

The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilar Hyrimoz (adalimumab) citrate-free high-concentration formulation (HCF). With eight marketed biosimilars, Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe, with more than two decades of experience.

Marketing

Marketing Medicine Packaging Packaging

New Weight Loss Drug May Launch in US After Promising Clinical Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 3, 2023

Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection. Eli Lilly said its […]

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

HCPs sound off on pharma marketing

World of DTC Marketing

APRIL 20, 2022

We just finished talking to over 200 hundred HCPs about pharma marketing and salespeople to measure any differences since before the pandemic. Attitudes are indeed changing, but one need remains clear: access to data obtained during clinical and ongoing trials. Will they transform their HCP marketing or stick to dated models?

Marketing

Marketing Drugs Drug Trials Sales

Strategies for effective biosimilar clinical trial design and execution

Drug Patent Watch

JANUARY 23, 2025

Designing the Future of Biosimilars: Strategies for Success As the biosimilar market continues to grow, pharmaceutical companies are facing increasing pressure to develop high-quality, cost-effective treatments that meet the evolving needs of patients and healthcare systems. What are your thoughts on the future of biosimilars?

Clinical Trials

Clinical Trials Clinical Trials Trials Production

MASH Clinical Trials: New Approaches and Methodologies

XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Nicola Owen, PhD, MBBS, Medical Directorthey shared insights into the operational and medical strategies that support the design and conduct of MASH clinical trials.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Pharmaceutical Technology

JULY 26, 2022

According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

Marketing

Marketing Gene Branding Clinical Development

Lilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial

Bio Pharma Dive

DECEMBER 4, 2024

Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.

Drug Trials

Drug Trials Trials Drugs Marketing

Bluebird resumes marketing gene therapy in Europe

Bio Pharma Dive

JULY 9, 2021

Zynteglo sales have been on hold since February, when a patient in a clinical trial of another, related Bluebird medicine developed leukemia.

Gene Therapy

Gene Therapy Gene Marketing Clinical Trials

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

Takeda discontinuing in AAV and rare haematology disease markets

Pharmaceutical Technology

APRIL 13, 2023

Takeda’s announcement underlines the risk associated with gene therapy R&D at the preclinical stage and the fact that many current AAV programs are unlikely to reach late-stage trials.

Gene Therapy

Gene Therapy Marketing Gene In-Vivo

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

Gene Therapy

Gene Therapy Clinical Supply Trials Gene

Schizophrenia trials continue to test drug candidates as Covid-19 pandemic continues

Pharmaceutical Technology

JULY 29, 2022

According to GlobalData’s Epidemiology and Market Size database, epidemiologists estimate there are more than 21 million prevalent cases within the tracked 16 countries. Last year saw the most with 167 trials. Cerevel Therapeutics has two Phase II/III trials and three Phase III trials planned.

Trials

Trials Drugs Clinical Trials Clinical Trials

For biotechs to attract investors think like marketers

World of DTC Marketing

FEBRUARY 15, 2022

Biotechs need to think like marketers to cut through the noise and attract investors. CEOs have to think like marketers to cut through the clutter with all the biotech startups out there. 2wo: Clinical trial data releases need to coincide with major medical conferences.

Marketing

Marketing Clinical Trials Clinical Trials Trials

Eloxx repackages ELX-02 data in cystic fibrosis as it eyes pivotal trial

Pharmaceutical Technology

JUNE 15, 2023

Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. The market responded warmly to the reanalysis. The regimen in the trial was a one-week monotherapy period (1.5

Trials

Trials Genetics Protein Marketing

Sanofi, Regeneron surge as Dupixent scores in COPD trial

Bio Pharma Dive

MARCH 23, 2023

The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

Antibody

Antibody Trials Medicine Marketing

GSK cancer drug Blenrep gets surprise trial win

Bio Pharma Dive

NOVEMBER 27, 2023

market because of negative data, new study results might crack open the door to a relaunch. One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S.

Drugs

Drugs Trials Marketing

Troubling data leads a biotech to pull its prized drug from market and FDA review

Bio Pharma Dive

APRIL 18, 2022

Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

Clinical Trials

Clinical Trials Clinical Trials Marketing Medicine

Strategies for Successful Navigation of Complex Radiopharmaceutical Trials

Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

Trials

Trials Clinical Trials Clinical Trials Compliance

When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog

JANUARY 30, 2025

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

Trials

Trials Drugs Cosmetics Development

Pfizer, Valneva take next step with Lyme disease shot, starting large trial

Bio Pharma Dive

AUGUST 9, 2022

The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.

Trials

Trials Vaccination Vaccine Marketing

Why Including Patients in FDA Engagement Will Benefit Your Trial

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

Trials

Trials Clinical Trials Clinical Trials Development

Eli Lilly's Zepbound defeats Novo Nordisk's Wegovy in head-to-head weight loss trial

Fierce Pharma

DECEMBER 3, 2024

Over the last two-plus years, as Eli Lilly and Novo Nordisk have battled for their share of the massive weight loss market and patients wondered which company’s products were more effective, there | Eli Lilly revealed results from a study that showed its obesity drug Zepbound was 47% more effective than Novo’s Wegovy in helping patients lose weight. (..)

Trials

Trials Production Marketing Drugs

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials

Trials Clinical Trials Clinical Trials Drugs

EMA validates Sobi’s marketing authorisation application for efanesoctocog alfa

Pharmaceutical Technology

MAY 22, 2023

The European Medicines Agency (EMA) has accepted and verified Sobi’s marketing authorisation application for a new factor VIII (FVIII), efanesoctocog alfa, to treat haemophilia A patients of all ages. In February 2023, the US Food and Drug Administration approved efanesoctocog alfa as ALTUVIIIO.

Marketing

Marketing Genetics Trials Medicine

FDA Approves Ensacove (Ensartinib) for Advanced NSCLC in Crowded ALK Inhibitor Market

XTalks

DECEMBER 19, 2024

Roches Alecensa is the current ALK inhibitor market leader. It entered the first-line ALK treatment landscape seven years ago following the Phase III ALEX trial. The trial demonstrated that Alecensa reduced the risk of disease progression or death by 47 percent compared to Xalkori.

FDA Approval

FDA Approval Marketing Trials Drugs

Drugmakers are racing to find the next Wegovy. These obesity trials are ones to watch.

Bio Pharma Dive

OCTOBER 10, 2024

Data readouts over the next six months could set expectations for how the highly lucrative market for weight loss therapies will look in the future.

Trials

Trials Marketing

Moderna says combination flu, COVID shot succeeds in study

Bio Pharma Dive

JUNE 10, 2024

Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.

Vaccination

Vaccination Vaccine Trials Marketing

Regulatory considerations for biosimilar clinical efficacy trials

Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

Trials

Trials Clinical Trials Clinical Trials Production

EC announces EU pharma reform that cuts market exclusivity

Pharmaceutical Technology

APRIL 27, 2023

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Along with the patent-related changes, the EC is seeking to ease some of the regulatory steps.

Marketing

Marketing Medicine Production Clinical Trials

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

Gene Therapy

Gene Therapy Gene Trials Clinical Trials

Blueprint drug succeeds in rare disease study important to its market prospects

Bio Pharma Dive

AUGUST 17, 2022

Trial results position the company to seek approval for indolent systemic mastocytosis, which executives have painted as a “multibillion dollar” market opportunity. Even so, shares fell by double digits in trading Wednesday.

Marketing

Marketing Drugs Trials

Lilly looks to speed FDA review of new diabetes drug in obesity

Bio Pharma Dive

OCTOBER 6, 2022

A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.

Drugs

Drugs Trials Marketing

Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

Bio Pharma Dive

DECEMBER 14, 2021

Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

Gene Therapy

Gene Therapy Licensing Licensing Gene

Partnering for success in early phase clinical development

Bio Pharma Dive

FEBRUARY 24, 2025

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

SEC recommends waiver of local phase III and IV trials for Sanofi’s orphan drug to treat Pompe disease

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The Committee recommended grant of permission to import and market the drug without these stages of studies.

Trials

Trials Clinical Trials Clinical Trials Drugs

Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing

Manufacturing Marketing Pharma Companies Vaccination

Boehringer Ingelheim advances weight loss drug to Phase III trials

Pharmaceutical Technology

AUGUST 18, 2023

Depending on Phase III results, survodutide could soon enter the weight loss market, which is expected to reach $37.1bn by 2031.

Trials

Trials Drugs Marketing

DCGI issues alert on suspected falsified GLP-1-RA products in the market

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 23, 2023

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]

Production

Production Marketing Regulation Drugs

As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial

Bio Pharma Dive

SEPTEMBER 27, 2021

Phase 3 results showed Merck's drug improved overall survival versus placebo, which should lessen pressure for a market withdrawal in the indication.

Trials

Trials Marketing Drugs

Pfizer to pull sickle cell drug from market, shut down trials

Roche, nearing major trial readouts, starts new Alzheimer's drug study

Trending Sources

BlueRock Advances Bemdaneprocel Cell Therapy to Phase III Trial for Parkinson’s Disease

Is biotech facing a long bear market?

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

New Weight Loss Drug May Launch in US After Promising Clinical Trial

HCPs sound off on pharma marketing

Strategies for effective biosimilar clinical trial design and execution

MASH Clinical Trials: New Approaches and Methodologies

Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Lilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial

Bluebird resumes marketing gene therapy in Europe

SEC recommends approval for MSN Laboratories’ sleep disorder drug

Takeda discontinuing in AAV and rare haematology disease markets

Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Schizophrenia trials continue to test drug candidates as Covid-19 pandemic continues

For biotechs to attract investors think like marketers

Eloxx repackages ELX-02 data in cystic fibrosis as it eyes pivotal trial

Sanofi, Regeneron surge as Dupixent scores in COPD trial

GSK cancer drug Blenrep gets surprise trial win

Troubling data leads a biotech to pull its prized drug from market and FDA review

Strategies for Successful Navigation of Complex Radiopharmaceutical Trials

When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

Pfizer, Valneva take next step with Lyme disease shot, starting large trial

Why Including Patients in FDA Engagement Will Benefit Your Trial

Eli Lilly's Zepbound defeats Novo Nordisk's Wegovy in head-to-head weight loss trial

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

EMA validates Sobi’s marketing authorisation application for efanesoctocog alfa

FDA Approves Ensacove (Ensartinib) for Advanced NSCLC in Crowded ALK Inhibitor Market

Drugmakers are racing to find the next Wegovy. These obesity trials are ones to watch.

Moderna says combination flu, COVID shot succeeds in study

Regulatory considerations for biosimilar clinical efficacy trials

EC announces EU pharma reform that cuts market exclusivity

SEC recommends phase III clinical trial waiver for Emcure’s HIV drug doravirine 100mg & its bulk drug

FDA suggests ways to curb constraints with rare disease gene therapy trials

Blueprint drug succeeds in rare disease study important to its market prospects

Lilly looks to speed FDA review of new diabetes drug in obesity

Rebounding from setbacks, Sanofi reveals promising data for hemophilia drug

Partnering for success in early phase clinical development

SEC recommends waiver of local phase III and IV trials for Sanofi’s orphan drug to treat Pompe disease

Brazil: untapped market for big pharma manufacturing

Boehringer Ingelheim advances weight loss drug to Phase III trials

DCGI issues alert on suspected falsified GLP-1-RA products in the market

As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial

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