Noxopharm cancer drug secures Orphan Drug Designation from FDA

Outsourcing Pharma

The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma. Markets & Regulations

Drugs 52

Pharma losing the battle over drug prices

World of DTC Marketing

According to the KFF poll “ most adults – across partisans – don’t believe high drug prices are needed for drug companies to invest in new research instead agreeing that “even if U.S. The post Pharma losing the battle over drug prices.


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Spectrum to lay off R&D staff after FDA drug rejection

Bio Pharma Dive

The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib

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

Pfizer, Roivant set up new company around inflammation drug

Bio Pharma Dive

The drug is currently in mid-stage testing as a treatment for ulcerative colitis. If it continues to advance, it could be the first approved therapy aimed at a protein known as TL1A, a target multiple other companies are pursuing

Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Since then, accelerated Approval has shifted focus to oncology drugs.

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

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.

Arrowhead capitalizes on Amgen drug progress with royalty rights deal

Bio Pharma Dive

The biotech will sell its royalty interest in a heart disease drug Amgen is developing for $250 million, extending its operating runway by several quarters

Are new weight loss drugs an answer or problem?

World of DTC Marketing

And the Covid-19 pandemic only underscored that obesity puts people at greater risk for infectious disease but are new weight loss drugs the answer? Novo Nordisk more than doubled its sales targets for obesity drugs to $3.7bn by 2025. As I See It Weight Loss Drugs

Expediting IND applications with drug master files

Bio Pharma Dive

By taking advantage of pre-filed DMFs, researchers benefit from the value, time savings and reduced complexities of having someone else do the heavy lifting for key components of the final drug product

Drug company profiteering

World of DTC Marketing

When drug makers like Xtandi’s manufacturer, Astellas Pharma, price gouge sick Americans, the U.S. The post Drug company profiteering. A cancer medication called Xtandi costs $189,800 per year and was developed with taxpayer dollars. The U.S.

How pharma can make drug information accessible


Pharmaceutical drugs can work wonders for patients, whether it’s treating rare diseases or easing everyday maladies. But drugs can also be complex. Also, the longer that a drug is on the market, the more its manufacturer might learn and document about its effects.

EQRx redraws ‘radical’ drug pricing plans for first two drugs

Bio Pharma Dive

The buzzy startup, which planned to undercut big pharma on price, also dropped plans to seek U.S. approval in lung cancer of an immunotherapy competitor to Keytruda

Drugs 220

The drug industry can’t fight change

World of DTC Marketing

While it’s true, the drug industry developed COVID vaccines; the government spent billions on research pre-pandemic and $18 billion more on trials, production, and purchase. Drug corps are reaping record profits. Drug companies should prepare for this scenario.

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

Ventus sells its lead drug candidate to Novo Nordisk

Bio Pharma Dive

The biotechnology startup will part with its lead drug candidate, an anti-inflammatory small molecule, in Novo Nordisk’s bet on inflammasome treatments

Drugs 267

Novartis prostate cancer drug succeeds in study key to company’s sales hopes

Bio Pharma Dive

The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market

Sales 246

Drug pricing increases are disgraceful

World of DTC Marketing

SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Drug Prices

FDA opens case to withdraw controversial drug for preterm births

Bio Pharma Dive

Beginning a high-stakes advisory meeting, CDER head Patrizia Cavazzoni said that Covis Pharma’s drug is ineffective and should not remain on the market

Boost agility and speed in your drug development research

Bio Pharma Dive

How flexible API access to integrated 'omics data helps boost agility and speed in drug research

BMS: Delayed new drug to avoid paying billions?

World of DTC Marketing

billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and Drug Administration approval for the non-Hodgkin lymphoma drug by a Dec.

Merck cardiovascular drug succeeds in study, validating $11B buyout bet

Bio Pharma Dive

The drug could help Merck fill an expected gap in revenue when patents on Keytruda expire Late-stage study results showed sotatercept, which Merck acquired via its Acceleron deal, benefited patients with PAH.

Drugs 259

Biogen, Denali begin late-stage testing of Parkinson’s drug

Bio Pharma Dive

Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2

Gene 265

GSK myeloma drug comes up short in confirmatory test

Bio Pharma Dive

The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020

Drugs 227

Biotech ObsEva sells drug rights to forestall funding crunch

Bio Pharma Dive

In an effort to extend its cash runway and keep its stock listing, ObsEva is offloading rights to an experimental preterm labor drug in a deal with Xoma

Drugs 185

Odyssey recruits news investors to fund precision drug research

Bio Pharma Dive

A $168 million Series B round brings Odyssey’s total funding to date near $400 million, helping the startup support a growing pipeline of cancer and immune disease drug candidates

Prescription drug prices are out of cotrol

World of DTC Marketing

This includes about one in five who report that they have not filled a prescription or took an over-the counter drug instead, and about one in ten who say they have cut pills in half or skipped a dose. Drug prices in the United States are extreme. Drug Prices

New cancer drug clinical trials struggling

World of DTC Marketing

This translates to longer development times for cancer drugs which means that cancer patients could suffer. It’s essential that drug companies get creative and find new ways to reach patients when incomes to cancer drug screening and clinical trials.

CinCor shares dive after blood pressure drug fails key trial

Bio Pharma Dive

The company, one of several developing a drug for treatment-resistant hypertension, had pulled off one of 2022’s top performing biotech IPOs prior to the results

Drug price negotiations on the horizon

World of DTC Marketing

SUMMARY: Democratic lawmakers are weighing whether to include drug pricing measures that could extract tens of billions of dollars from the industry. We’re just not sure when,” said one drug industry lobbying source. The drug industry has had a large target on its back for a long time.

MEI, Kyowa stop lymphoma drug trials after FDA meeting

Bio Pharma Dive

regulators’ recent moves to closely evaluate a class of drugs known as PI3 kinase inhibitors The decision not to run a Phase 3 trial of their medicine is the latest fallout from U.S.

Acelyrin sets hopes high for arthritis drug with $300M fundraise

Bio Pharma Dive

The well-funded startup is planning Phase 3 trials for a drug it claims could be superior to top-selling medicines from Novartis and others

Trials 237

Prometheus shares soar on new data for inflammation drug

Bio Pharma Dive

Having scored positive results in two key studies for ulcerative colitis and Crohn’s disease, Prometheus now intends to advance the drug, called PRA023, into pivotal testing

Drugs 130

First-of-its-kind Type 1 diabetes drug wins FDA approval

Bio Pharma Dive

To be sold as Tzield, the drug will cost $193,900 for a typical full regimen Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes.

Alnylam details anticipated results from heart disease drug trial

Bio Pharma Dive

Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug

When Abortion Pills Were Banned in Brazil, Women Turned to Drug Traffickers

NY Times

Abortion Telemedicine Abortion Drugs Drugs (Pharmaceuticals) Women and Girls Brazil your-feed-healthcareWith Roe v. Wade overturned, states banning abortion are looking to prevent the distribution of abortion medication. Brazil shows the possible consequences.

Drugs 108

Gilead, with new results, doubles down on breast cancer drug

Bio Pharma Dive

The company has agreed to spend at least $280 million buying back rights to the drug, called Trodelvy, which were sold to Everest Medicines in 2019

Clinical trial DTC? It may not be right for your drug candidate

World of DTC Marketing

The FDA approved 309 new drugs between 2011 and 2018, 38 per year on average. In 2018, the FDA approved 59 new drugs – an all-time high. The industry loses an average of $40 billion per year on drug development, part of which is due to trial delays.

Covid Drugs Save Lives, but Americans Can’t Get Them

NY Times

Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Health Insurance and Managed Care Doctors Vaccination and Immunization Paxlovid (Drug) Evusheld (Drug) Pfizer Inc United StatesOnce again, a dysfunctional health care system has hindered our pandemic response.

Bristol Myers' autoimmune drug shows potential in lupus

Bio Pharma Dive

Positive Phase 2 results could help boost company executives' arguments that the drug, called deucravacitinib and under FDA review in psoriasis, will become a top-seller

Drugs 270

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

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