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While many companies are still unsure of the law’s effects, some have begun to warn investors about the likelihood of lower sales and reduced profitability...Biotechnology and pharmaceutical companies are still parsing the U.S. drug pricing law enacted in August, but recently have begun to warn investors of looming impacts to their development plans and to future sales...In regulatory filings and earnings calls over the past few weeks, major drugmakers described significant uncertainty over how the law will be implemented and how it might directly affect their business. But some have been more specific, with Merck & Co. and Amgen noting they expect it to impact future sales. And a few, including Eli Lilly, Alnylam Pharmaceuticals and Alkermes, have cited the law specifically in decisions to cut back or reshape their drug research...READ MORE

CPI, one of the founding partners in the Medicines Manufacturing Innovation Centre, has announced the signing of an agreement with PwC, making the company the latest partner in the collaborative effort. The Centre (established via a partnership among CPI, the University of Strathclyde, UK Research and Innovation, Scottish Enterprise and founding industry partners AstraZeneca and GSK) seeks to promote more innovative drug manufacturing processes and enable a more agile supply chain...PwC and the existing partners will work to maximize technological opportunities across the pharma supply chain. Efforts include...projects, intended to advance emergent and disruptive technologies. The program is partially funded by Innovate UK through the Industrial Strategy Challenge Fund and Scottish Enterprise via the Scottish Government...READ MORE

The COVID-19 pandemic has raised the profile of mRNA vaccines in a dramatic way in about a year. Looking forward, the technology holds more promise and could displace traditional shots in some diseases, experts said, but it's not time to give up on well-known vaccine platforms, either...researchers at Moderna...reached human testing for their mRNA vaccine in record time. And separately, in under a year of development, testing and manufacturing, Pfizer and its mRNA partner BioNTech were able to score an FDA emergency use authorization last December...In addition to being able to rapidly advance new vaccines in response to emerging threats, the “beauty” of the platform is that the production process is “universal,"...Still, it’s not time to go all-in on mRNA... While experts are clearly enthusiastic about the platform, that “doesn’t guarantee that mRNA will immediately work against all pathogens,"...READ MORE

Cancer cells could play a key role in the delivery of tumor-fighting drugs, thanks to a new DNA transport system that keeps its therapeutic payload locked away until it comes into contact with diseased cells...Scientists at the Technical University of Munich and the KTH Royal Institute of Technology...say they’ve developed a synthetic DNA transport system for targeted delivery of cancer drugs...the team has created a nano-carrier using mucin, glycerol and synthetic DNA, which wraps up cancer drugs in a secure package that can only be unlocked by a certain RNA sequence unique to diseased cells...READ MORE

Drug development is expensive, can take years to complete and doesn't guarantee a novel therapy for treating disease...But consumer genetic testing company 23andMe is forging ahead to leverage its massive database of genetic data for research and to make and sell its own therapies...Using genetic data based on the company's 12 million genotype customers and billions of phenotypic data points gives 23andMe a distinct competitive advantage for its therapeutics business, Kenneth Hillan, 23andMe’s head of therapeutics, said..."We talk about it as our secret power. It really is that statistical power, the size and scale of our databases, and using genetics to see things in terms of drug targets within diseases that others just can't see," he said...READ MORE

Moderna announced it has started development on a booster to its COVID-19 vaccine, which the company hopes will work against the recently discovered (and more transmissible) SARS-CoV-2 variant from South Africa...Moderna’s COVID-19 vaccine mRNA-1273 appears to be effective for protecting against B.1.1.7 and B.1.351, two highly infectious strains first discovered in the U.K. and South Africa, respectively...The South African B.1.351 variant features ten mutations found in the spike protein of SARS-CoV-2, the novel coronavirus responsible for COVID-19. Variants from both the U.K. and South Africa have spread quickly across the globe, with some data suggesting these variants are associated with increased transmission and greater post-infection viral burden...READ MORE

Three leaders from pharma ingredients and innovation firm Lonza share views on challenges and opportunities likely to face the industry in coming months...It likely is safe to say no professionals in drug development and manufacturing has a reliable crystal ball that can provide a crystal-clear picture of exactly what will happen in the coming 12 months. However, seasoned and savvy professionals can offer educated opinions, and advice on preparing for what might lie ahead...To get a clearer perspective on what 2021 might have in store for the pharma field, Outsourcing-Pharma (OSP) checked in with three Lonza executives, asking their thoughts on 2020 as well as the new year...READ MORE

When posed with the decades-old question of how drug price reform would affect their operations in the U.S., pharma execs have a ready-made response: Reducing drug prices would hinder innovation...While Eli Lilly CEO David Ricks falls in line with the mantra, he bolsters his case with a cautionary example, pointing to Europe and the effect government pricing regulations have had there...“In the 80s and 90s, this was a European industry,” Ricks said in an interview. “Eighty percent of global R&D was happening on the European continent and today it’s less than 20. Where’s that going? It’s gone to America.”...READ MORE

Merck announced that it is going to stop developing its two COVID-19 vaccine candidates, dubbed V590 and V591, after poor responses in Phase I trials. They are shifting their attention to advancing two therapeutic drugs for COVID-19, MK-4482 and MK-7110...“We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dean Y. Li, president, Merck Research Laboratories. “We are resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, health care systems and communities.”...READ MORE

Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc...Medical experts said more data is needed to assess the treatment’s efficacy before wider use should be allowed...The company said...that it has submitted a request to the U.S. Food and Drug Administration for an emergency use authorization for its antibody combination...READ MORE