Sat.Jul 10, 2021 - Fri.Jul 16, 2021

article thumbnail

Biohaven CEO on migraine drug's fast launch, TikTok ads and battling big pharma

Bio Pharma Dive

Sales of Nurtec ODT during the second quarter were double what Wall Street expected. CEO Vlad Coric explained to BioPharma Dive how the biotech did it, despite being far smaller than its chief rival.

Sales 334
article thumbnail

Who do you trust? The FDA vs. Pfizer

World of DTC Marketing

SUMMARY: Pfizer says it has data on waning immunity from their COVID vaccine. The FDA and CDC say “not so fast.” Booster shots could bring billions in revenue to Pfizer and Moderna. The media is using scare headlines and is not always presenting accurate stories. Patients are left to wonder if they need a booster shot creating anxiety as a new strain emerges.

Vaccine 292
Insiders

Sign Up for our Newsletter

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

article thumbnail

New hope for long COVID blood tests after antibody discovery

Pharma Times

Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms

Antibody 181
article thumbnail

Johnson & Johnson Recalls Sunscreen Because of Benzene Traces

NY Times

The company said it had determined that daily exposure to five Neutrogena and Aveeno sprays would not cause adverse health effects, but recalled the products out of an abundance of caution.

article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

Merck details an immunotherapy 'milestone' in early breast cancer

Bio Pharma Dive

Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.

Drugs 328
article thumbnail

The REAL threats to DTC advertising

World of DTC Marketing

SUMMARY: There is a talent drain at the agency and DTC levels. More experienced DTC people are being forced to retire. TV still gets the biggest share of DTC budgets, but they don’t drive brand objectives. Talented marketers don’t want a career in pharma because of the culture. Many pharma agencies have allowed and sometimes forced experienced, talented people to leave while replacing them with inexpensive unproven people, and it shows.

More Trending

article thumbnail

NICE to develop guideline for rare blood clots associated with COVID-19 vaccination

Pharma Times

Condition is 'extremely' rare, with only 14.

Vaccine 141
article thumbnail

FDA flags rare side effect in new warning on J&J's coronavirus vaccine

Bio Pharma Dive

The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of a immune-driven condition known as Guillain-Barré

Vaccine 328
article thumbnail

Biogen is in deep trouble and may not survive

World of DTC Marketing

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug. Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.

article thumbnail

ACD/Labs, Science Data Experts establish AI partnership

Outsourcing Pharma

The two companies will work together to come up with solutions that use machine learning and artificial intelligence to help accelerate innovation in R&D.

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

Aetion and Cegedim expand real-world data partnership

Pharma Times

In 2020, the two partners announced an initial collaboration to integrate Cegedim’s ‘THIN’ European real-world data into Aetion’s evidence platform

140
140
article thumbnail

Major health centers, insurers push back against Aduhelm

Bio Pharma Dive

The Cleveland Clinic and Mount Sinai won't yet administer the controversial Alzheimer's drug, while UnitedHealth's CEO said the insurer would need more time to iron out coverage.

Drugs 325
article thumbnail

Drug companies know how to play the FDA drug approval process

World of DTC Marketing

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. The FDA has been under criticism, but an internal investigation will focus on approval processes, not “why” a drug was approved.

Drugs 187
article thumbnail

Understanding the Link Between Alcohol and Depression

Pharma Mirror

Alcohol abuse is closely correlated with depression. This doesn’t necessarily mean one causes the other, but many people who suffer from depressive disorders turn to alcohol to escape. On the other side of that coin, those who abuse or overuse alcohol can develop symptoms of depression or exacerbate symptoms that are already present. So, how are these two issues related, and how can you help a loved one if you start to notice alcohol-induced depression or depression-induced alcohol abuse?

article thumbnail

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

article thumbnail

PHE study finds COVID-19 vaccines ‘highly effective’ in at-risk groups

Pharma Times

Vaccine effectiveness against symptomatic disease in at-risk groups is approximately 60% after one dose of either the AZ or Pfizer/BioNTech vaccines

Vaccine 137
article thumbnail

Questions on new Alzheimer's drug benefit, price loom large at ICER meeting

Bio Pharma Dive

"Right now, and I think for a while, the access is going to be pretty limited," former CMS and FDA head Mark McClellan said at the meeting, which featured yet another rebuke by experts of Aduhelm.

Drugs 319
article thumbnail

Digitisation key to improving mental health services in England; report

pharmaphorum

Faced with a looming mental health crisis, the UK government has been urged to invest in the digitisation of service provision across the NHS in England in a new report from think tank Future Care Capital. The study’s author – FCC’s head of policy and research Dr Peter Bloomfield, argues that there has been a lack of support for mental health services for many years in the UK, and the pathways for accessing them are “convoluted, waiting lists are extensive, and outcomes are po

article thumbnail

USC study shows dire impacts downstream of Nile River dam

Scienmag

The research forecasts water supply and economic risks as tensions mount over Grand Ethiopian Renaissance Dam Credit: (Photo/NASA-JPL) Rapid filling of a giant dam at the headwaters of the Nile River — the world’s biggest waterway that supports millions of people — could reduce water supplies to downstream Egypt by more than one-third, new USC […].

Research 119
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

article thumbnail

Galapagos’ filgotinib leads to rapid symptom improvement for ulcerative colitis patients

Pharma Times

Data also suggested filgotinib 200mg reduced and eliminated corticosteroid use compared to placebo

135
135
article thumbnail

Prime Medicine raises $315M to fuel 'search-and-replace' gene editing work

Bio Pharma Dive

Formed around research from the Broad Institute's David Liu and Andrew Anzalone, Prime has attracted significant funding from a wide range of high-profile biotech backers.

article thumbnail

UK fines drugmakers record £260m for price gouging NHS

pharmaphorum

The UK’s competition authority has issued its largest ever fine of more than £260 million ($360 million) to several pharma companies accused of colluding to hike the price of medicines delivered to the NHS. The Competition and Markets Authority (CMA) took the action against Auden Mckenzie and Actavis UK – now known as Accord-UK – and other companies after an investigation into the price of hydrocortisone tablets, which rose by 10,000% over a 10-year period.

Marketing 119
article thumbnail

F.D.A. Attaches Warning of Guillain-Barré Syndrome to Johnson & Johnson Covid Vaccine

NY Times

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

Vaccine 116
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Merck’s MET inhibitor tepotinib gains positive opinion from MHRA

Pharma Times

The positive opinion has been issued via the MHRA’s early access the medicine (EAMS) scheme

Medicine 130
article thumbnail

Lilly wagers up to $1B on a biotech's plan for a new type of insulin

Bio Pharma Dive

Rival Novo Nordisk has jumped ahead in developing an injectable drug that responds to changes in blood sugar. An acquisition of Protomer Therapeutics could help Lilly close the gap.

Insulin 299
article thumbnail

What HCPs think about health equity in cancer care

pharmaphorum

After more than a year of COVID-19 dominating health conversations, HCPs have been engaging in dialogue about continually evident disparities that many are facing in healthcare. CREATION.co’s Mary Kangley explores what HCPs think about health equity in cancer care. The topic rose to significance in the American Society of Clinical Oncology (ASCO) whereby they updated their mission statement in 2020 to “Conquering cancer through research, education, and promotion of the highest quality, equ

article thumbnail

Man vs. Machine – Which is Best at Predicting Clinical Trial Outcomes?

BioSpace

A recent Deny-Colton Virtual Salon pitted human intelligence against AI/ML to weigh not just the outcomes, but the process.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

NHS invests £20m to fast-track measures for quick cancer diagnosis

Pharma Times

Funding will go towards a number of measures aimed at speeding up cancer diagnosis and treatment

130
130
article thumbnail

Biogen chases rivals with another bet on emerging class of multiple sclerosis drugs

Bio Pharma Dive

A deal with Innocare gives Biogen a second therapy for MS that targets a protein called BTK, an approach several other competing drugmakers are pursuing, too.

Protein 290
article thumbnail

AZ, J&J tweaking COVID shots to reduce clotting risks; report

pharmaphorum

AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help doctors manage the cases of vaccine-induced immune thrombocytopenia and thrombosis (VITT) and low blood platelet counts that have been seen with the COVID-19 va

Vaccine 116
article thumbnail

Will Plant-Based Meat Prices Ever Be Lower Than Real Meat?

XTalks

Since its inception, plant-based meat has commanded a premium in most grocery stores and restaurants. Despite being inherently more efficient to produce — since it relies on plants rather than animals — plant-based meat is often more expensive than its animal-based counterpart. . Is it because of the technology required to produce it? Perhaps the profit margins?

Protein 105
article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.