2022

FDA approves first microbiota-based treatment

Bio Pharma Dive

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection

Digital health is overrated but there is a future

World of DTC Marketing

The continued emphasis on digital health is overrated but digital health will become an integral part of total patient care. To become a vital part of patient care, digital health providers need to provide the medical community with studies that show their value to patient outcomes.

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What to make of Eisai and Biogen’s latest Alzheimer’s drug data

Bio Pharma Dive

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits

FDA approves first gene therapy for hemophilia B

Bio Pharma Dive

The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

TherapeuticsMD to offload drugs to Australia’s Mayne after failed buyout

Bio Pharma Dive

After a private equity takeover unraveled this summer, the women’s health company is selling its drug portfolio to Mayne Pharma in a $153 million deal

Drugs 263

Building a biotech in a downturn: 3 lessons from VCs and startup CEOs

Bio Pharma Dive

In a panel discussion hosted by BioPharma Dive, venture capitalists and CEOs discussed how startups can navigate a challenging market as well as possible ripple effects from the new U.S. drug pricing law

More Trending

Sana reshuffles drug pipeline, becoming latest biotech to cut staff

Bio Pharma Dive

The richly funded drugmaker will cut 15% of its workforce, or about 75 employees, as well as stop work on one of its preclinical research programs

Biotechs reveal layoffs, research revamps in third quarter earnings

Bio Pharma Dive

Tricida, Harpoon, Freeline and three other small drug developers have this week announced plans to cut staff or to reprioritize their drug development

Drugs 275

CAR-T pioneer Carl June on founding biotech startups and cell therapy’s next act

Bio Pharma Dive

The University of Pennsylvania immunologist and inventor of Kymriah spoke with BioPharma Dive about working with pharma, starting companies and the future of the cell therapy field

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Freeline cuts back as it continues search for gene therapy partner

Bio Pharma Dive

The U.K. biotech will sell its German unit and lay off staff to save cash as it focuses on therapies for Gaucher and Fabry diseases

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.

ALS drug approved by FDA in closely watched decision, marking win for patients, developer

Bio Pharma Dive

The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders

What to look for when hiring in pharma

World of DTC Marketing

The great resignation has not affected pharma because the jobs within the industry pay very well and most positions and employees like the benefit of having a steady job with good money.

In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial

Bio Pharma Dive

The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s

Trials 285

Prime Medicine raises $175M in one of the year’s largest biotech IPOs

Bio Pharma Dive

The gene editing startup is one of less than two dozen biotech companies to debut on Wall Street this year, as the pace of IPOs remains far off last year’s trajectory

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

String of gene therapy deals spurs cautious optimism on Wall Street

Bio Pharma Dive

To some analysts, the recent acquisitions of Akouos and AGTC, as well as Astellas’ equity investment in Taysha, are a positive signal for an area of drug research that’s been “in investors' penalty box for much of 2022 &rdquo

Rigel wins US approval of rival drug to Servier leukemia treatment

Bio Pharma Dive

The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo

Bispecific cancer drugs and gene therapy advances: What to watch at next month’s ASH meeting

Bio Pharma Dive

Competition is increasing behind newly approved drugs from Roche and J&J, while the long-term benefit of gene therapies for chronic blood disorders is being put to the test

A Versant-backed biotech emerges to take on ‘overlooked’ cancer targets

Bio Pharma Dive

Nested Therapeutics touts a deep bench of scientific leaders and advisers, including Kevan Shokat, whose work drugging KRAS — a cancer-related gene once thought to be undruggable — helped lead to the development of Amgen’s Lumakras

Gene 282

Artiva cancels IPO plans and cuts a deal with Affimed

Bio Pharma Dive

With public offerings difficult to pull off, Artiva is focusing its energy on a cancer drug deal with the German biotech

Drugs 274

Sarepta asks FDA to approve first gene therapy for Duchenne muscular dystrophy

Bio Pharma Dive

The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials

Acrivon cuts IPO price to raise $99M for plan to revive old Lilly cancer drug

Bio Pharma Dive

Acrivon is the 20th biotech company to go public this year, roughly a fifth of last year’s total at this time, and had to sell more shares at a lower price to complete the deal

Drugs 268

AstraZeneca to acquire gene editing biotech LogicBio

Bio Pharma Dive

Shares in LogicBio had lost nearly all their value since a 2018 IPO, bringing the company to the brink of Nasdaq delisting. The buyout deal represents a premium of over 600

Amazon’s big gamble

World of DTC Marketing

Quick Read: Amazon will dramatically expand its healthcare reach with its planned $3.9 billion acquisition of One Medical, a primary care provider with 188 offices in 25 markets nationwide but are they making a strategic move or a mistake?

With new startup, immunotherapy pioneer Lieping Chen tries to turn ‘cold’ tumors ‘hot’

Bio Pharma Dive

Chen, who discovered the cancer-protecting protein PD-L1, will work closely with startup Normunity to find targets that can help the immune system reach ‘cold’ tumors

Biogen names former Sanofi head Viehbacher to replace Vounatsos as CEO

Bio Pharma Dive

Viehbacher, who ran Sanofi from 2008 to 2014, will take over as CEO on Nov. 14, more than six months after Biogen began its search for a new leader

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Pfizer planning steep price hike for COVID-19 vaccine

Bio Pharma Dive

The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market

Sales 276

Bluebird wins FDA approval of gene therapy for rare brain disorder

Bio Pharma Dive

The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million

Early data hint at benefit for Amgen’s obesity drug

Bio Pharma Dive

Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk

Drugs 270

Bluebird gene therapy approved by FDA for rare blood disease

Bio Pharma Dive

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.

5 questions facing drugmakers as third quarter earnings begin

Bio Pharma Dive

The newly enacted drug pricing law, along with Eisai and Biogen’s Alzheimer’s study success, will bring questions for many of the industry’s top companies

Drugs 275

Gilead, fueled by latest approval, sees CAR-T sales take off

Bio Pharma Dive

After a slow start, Gilead’s CAR-T business is growing fast, enabling it to pull ahead of rival cell therapy developers like Bristol Myers Squibb and Johnson & Johnson

Sales 272

Star Therapeutics launches Vega, growing its galaxy of drug startups

Bio Pharma Dive

The second startup to emerge from Star’s “hub-and-spoke” model aims to develop a Hemlibra-like antibody drug for the blood clotting disorder von Willebrand disease

FDA lifts pause on Beam plans to test base editing cancer therapy

Bio Pharma Dive

The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously

Gene 252

The futility of banner ads

World of DTC Marketing

Digital ad spending in the industry will reach $15.84 billion in 2022. Although growth in digital budgets is slowing, we estimate the category will see nearly $20 billion in spending in 2024.