biopharma nl

3 changes coming to drug pricing

  • by

No matter if Democrats or Republicans are running the show in Washington, here are three solid bets for pharma companies to plan for in the changing drug-pricing landscape

How eConsent empowers more participant engagement in clinical trials

  • by

Creating the simplest process for informed consent benefits the potential participant by allowing them the time and resources to understand fully what they are consenting to. Through eConsent processes, research also opens the door to a more diverse population to engage in trials.

Decentralized clinical trials are opening the drug development pipeline

  • by

With the emergence of smart and connected devices and technologies, CROs and life sciences organizations are able to more easily perform decentralized, virtual clinical trials. Now, industry leaders are on a mission to make the practice of administering decentralized clinical trials the norm.

5 AI lessons from pharma world learned during Covid-19

  • by

With the increased reliance on digital technologies, pharma companies’ outreach to healthcare providers needs to be thoughtful, efficient, and respectful. An AI-driven, omnichannel strategy makes this possible by giving every member of customer-facing teams visibility across communications.

AstraZeneca updates Covid-19 vaccine data, now showing 76% efficacy

  • by

AstraZeneca’s latest efficacy data for its Covid-19 vaccine are down slightly from the 79% it previously reported. The most recent data will form the basis of an application for emergency use authorization, which the company still expects to file with the FDA in coming weeks.

In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]

  • by

Ho Sung Cho, senior vice president of Biodiscovery Therapeutics at Bristol Myers Squibb, talks about lessons learned from drug discovery, recent success tied to Covid-19, and how the company is leveraging its expertise in protein degradation to develop novel therapies for blood cancers, solid tumors… Read More »In MedCity Pivot podcast, biopharma researcher talks about protein degradation, recent success tied to Covid-19 [Sponsored]

AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions

  • by

Federal health authorities say safety observers are concerned AstraZeneca did not release complete information about the efficacy of its Covid-18 vaccine. The company responded by saying its data were from a pre-specified analysis and it will provide the most up to date efficacy data within… Read More »AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions

Antibody testing can improve efficiency in limited vaccine supply

  • by

Given our current limited supply, the threat of variant spread, and availability of higher quality antibody test kits, policymakers ought to update their vaccine guidance for those who had Covid and incorporate recent research findings on immunity and vaccine efficacy.

How Covid-19 is changing rare diseases research

  • by

While Covid has made many aspects of living with a rare disease more difficult, it has inspired policies and techniques that could help rare disease research progress more smoothly both during and after the pandemic.

4 signs your compliance program is out of date

  • by

Many players in life sciences and other sectors balk at updating their compliance systems because of the cost and resources involved. but addressing possible lapses now can save your company millions of dollars in fines and reputational damage.

Startup banks on immune-system memory to tackle cancer

  • by

Loki Therapeutics is advancing research that leverages the immune system’s ability to recall childhood vaccinations and direct it against cancer. The company’s lead therapy candidate could enter phase 1 clinical trials this year.

Key takeaways from BioNTech CEO’s JPM presentation

  • by

Ugur Sahin presented a sweeping vision of the company’s goal to become a next-generation immunotherapy company leveraging the messenger RNA platform technology that has won it acclaim and financial returns during the Covid-19 pandemic.

Can we warp-speed antibiotic development? 

  • by

Advocates, industry leaders and legislators have come to a consensus about the scope and urgency of the crisis related to inadequate development of antibiotics. They are calling for legislative fixes to protect public health.

FDA gives nod to Moderna vaccine for Covid-19

  • by

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

FDA gives emergency OK to Pfizer and BioNTech vaccine

  • by

The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s White House, renewing concerns that politics drove the vaccine process even as the first doses are shipped.

AI offers promise but faces barriers in drug development

  • by

Inertia is a barrier as is the traditional split between the clinical and the data-driven spheres of drug development. While smaller firms have an edge in bridging the gap, big pharma will eventually get there, said panelists at the INVEST conference session.

A proliferation of genetic testing options brings new challenges

  • by

In the last 20 years, access to genetic testing has expanded significant as technology has advanced. But there’s still lots of work to be done to get tests covered and make them more accessible, panelists said at a virtual conference hosted by MedCity News.

Level Ex pitches gaming as a tool for reaching doctors

  • by

Interactive, cloud-based video games are designed to tackle pharma’s current challenge: engaging doctors virtually during a pandemic. But the tools are likely to outlive the circumstances in which they were born.

Important questions about Pfizer’s Covid-19 vaccine

  • by

News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

To avoid crisis, pharma must address costs

  • by

Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach a crisis point, according to a panel of industry experts.

Bayer paying up to $4B for gene therapy pioneer AskBio

  • by

The deal, offering $2 billion up front and $2 billion in future milestone payments, includes a gene therapy manufacturing facility and a pipeline that includes treatments for Parkinson’s and congestive heart failure.

AI drug-discovery firm lands first partnership

  • by

The deal with Roche subsidiary Genentech is likely not the last for Genesis Therapeutics, which is based on AI research undertaken at Stanford. Such partnerships are potentially lucrative for drug-discovery startups.

Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals

  • by

The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.

Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M

  • by

The charges, filed in Philadelphia federal court, allege that Teva conspired with four other generic drug companies to fix prices, rig bids and allocate customers. Teva – which the Justice Department and New York’s state government also sued this month for unrelated allegations – said… Read More »Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M

J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]

  • by

In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has… Read More »J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

  • by

While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science… Read More »FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

J&J to buy Momenta Pharmaceuticals for $6.5B

  • by

The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.

Founders’ story: Pleiogenix

  • by

Pleiogenix is a biopharma startup developing treatments for liver diseases as well as Covid-19 and non-alcoholic steatohepatitis (NASH). It recently emerged as the winner of the INVEST Pitch Perfect contest for the biopharma track.

GSK nabs FDA approval for first-in-class multiple myeloma drug

  • by

Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.