2021

New Merck study results raise questions about its COVID-19 pill

Bio Pharma Dive

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday

Trials 281

Developmental and Reproductive Toxicology (DART) Studies: What Are They, and How Do They Fit into Your Program?

Camargo

Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings.

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HCPs use of digital

World of DTC Marketing

SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content.

Cystic Fibrosis Market: A Rapidly Expanding Playing Field for Mid-Cap Pharma

Delveinsight

Cystic Fibrosis is a rare inherited disorder that causes loss of lung function and damages the digestive system. It has a higher prevalence in the Caucasian population.

RNA 52

Lessons in Supply Chain Digitization from PepsiCo and Conagra

Speaker: Craig Weiss, ConAgra Brands; Mari Roberts PepsiCo; and Matt Elenjickal, FourKites

Supply chain digitalization is key to success as market volatility, widespread disruption & stiff competition for consumer dollars puts pressure on every aspect of the supply chain. Register to hear how 2 global brands are accelerating digital transformation and increasing efficiency & automation throughout their operations.

Drug Prices Are Up Again in 2021 and Canada’s PMPRB is On My Mind

Pharmacy Checkers

This week the prices of over 500 drugs went up in America, according to drug price transparency non-profit organization 46Brooklyn. This happens every year, usually coinciding with shouts of anger and disgust with the pharmaceutical industry’s greed.

HR 53

Open Source “Wikipedia” for Drug Discovery

Pharma Mirror

By Kambiz Shekdar, Ph.D. Open source drug discovery was proposed in the past in connection with third-world diseases like tuberculosis and malaria, but it is in the context of first-world indications where it is needed most.

More Trending

Why natural language processing (NLP) is a critical part of your real world data strategy

Bio Pharma Dive

The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content

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Is pharma hiring the right people?

World of DTC Marketing

SUMMARY: Older, more experienced employees are being shoved aside in favor of more inexperienced ones. The culture within pharma is driving people away, including new hires. More and more meetings are based on ROI, not the voice of the patient.

8 amlodipine alternative drugs for blood pressure

Druggist

Amlodipine is one of the most commonly prescribed drugs in the UK and the most prescribed high blood pressure ( BP ) medication. When patients are diagnosed with high blood pressure and a drug is recommended, amlodipine may be the first choice, but not always.

Drugs 87

Bluebird hit with another hold for sickle cell gene therapy

Bio Pharma Dive

Study enrollment and treatment of sickle cell patients under 18 will be paused for safety reasons, another hurdle in a series of setbacks for the company

3 Ways End-to-End Visibility Helps Minimize the Risks of Ocean Freight

Download this playbook to learn how end-to-end visibility helps to mitigate risk associated with the ocean freight market.

US pauses distribution of Regeneron, Lilly antibodies over omicron concerns

Bio Pharma Dive

The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread

Moderna founder unveils new drug company focused on a different kind of RNA

Bio Pharma Dive

Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules

RNA 283

A serial biotech entrepreneur launches his next startup with high-dollar backing

Bio Pharma Dive

Founded and led by Gary Glick, Odyssey Therapeutics has raised $218 million in an initial fundraising round for its cancer and inflammatory disease drug research

Drugs 277

Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Bio Pharma Dive

Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness

4 Silver Linings of the Chaotic Ocean Freight Market

Speaker: Peter Tirschwell, Chris Stauber, Sarah Barnes Humphrey, and Audrey Ross

Join this webinar exploring the silver linings that have emerged from the chaotic ocean freight market. The discussion will highlight solutions that prioritize digitization and build a more efficient international supply chain. Jan 25 at 10am CT.

Moderna vaccine weaker against omicron, but third shot boosts protection

Bio Pharma Dive

As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version

A high-profile gene therapy biotech takes aim at Huntington's

Bio Pharma Dive

Passage Bio and the University of Pennsylvania's Gene Therapy Program said they have begun preclinical research aimed at simultaneously developing multiple approaches to treating Huntington's

Sanofi to buy cancer immunotherapy biotech for $1B

Bio Pharma Dive

The French drugmaker is interested in Amunix Pharmaceuticals' technology, which could allow for more precise delivery of biologic drugs into cancerous tissue

Drugs 270

A three-decade monopoly: How Amgen built a patent thicket around its top-selling drug

Bio Pharma Dive

Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved

Drugs 279

The Smart Data Revolution: How AB InBev Drives Efficiency with Visibility Data

Speaker: AB InBev and FourKites

Register for our upcoming webinar to learn how leveraging the right data to make quick, well-informed decisions is the key to success in supply chain & logistics. Join FourKites and AB InBev to learn what’s possible with a data-driven supply chain strategy & real-time transportation visibility.

Blaming the anti-vaxxers is not the answer

World of DTC Marketing

SUMMARY: Anti-vaxxers are vocal, and the media amplify their voices. There are many reasons why people aren’t getting vaccinated. We need more data to understand why. Republican extremism is part of the problem, but so is the lack of education.

Relay's targeted cancer drug could be safer than its competitors. Is it more effective?

Bio Pharma Dive

Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too

FDA panel, after debate, narrowly backs Merck COVID pill

Bio Pharma Dive

While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease

Drugs 274

Pfizer, Merck launch large new trials of oral COVID-19 drugs

Bio Pharma Dive

Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year

Trials 285

Modernizing Pharmaceutical Supply Chains

Speaker: Nimesh Patel, Gregory Demitrack, and Sarah Barnes Humphrey

Register for our upcoming webinar to better understand the state of the pharmaceutical supply chain. FourKites partnered with Accenture to survey supply chain executives working in pharmaceuticals, biotech, cell and gene therapy, medtech, and other related industries.

CAR-T therapy trials show promise for earlier use in lymphoma

Bio Pharma Dive

Study results presented at ASH suggest Gilead's Yescarta and Bristol Myers Squibb's Breyanzi could become replacements for stem cell transplants in treating the blood cancer

Trials 271

FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

Bio Pharma Dive

On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice

Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms

Bio Pharma Dive

Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter

After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Bio Pharma Dive

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months

Drugs 283

Minimizing Retail Supply Chain Disruptions in 2021 and Beyond

Speaker: Izaac Moran, Customer Success Manager, FourKites; Glenn Koepke, SVP of Customer Success, FourKites; and featuring interviews with supply chain experts from Dollar Tree and Best Buy

Register for our upcoming webinar to see how savvy retailers including Dollar Tree and Best Buy are leveraging real-time visibility across their end-to-end supply chains in creative ways to drive agility and thrive in today’s unpredictable environment.

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

Bio Pharma Dive

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

COVID-19 pill from Pfizer authorized by FDA in major pandemic milestone

Bio Pharma Dive

Paxlovid is the first oral treatment for COVID-19, a potentially valuable new tool as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S.

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FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

Bio Pharma Dive

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country

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Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings.

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.