STAT

FEBRUARY 15, 2023

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.

Vaccines 364

Vaccines 364

PharmaVoice

FEBRUARY 13, 2023

Why the recently appointed president of commercial solutions sees near limitless potential to expand Klick’s footprint across the life sciences — and how generative AI is playing a role.

264

264

European Pharmaceutical Review

FEBRUARY 24, 2023

University Hospital Erlangen in Germany is the first in the world to use chimeric antigen receptor (CAR) T-cells to successfully treat a patient suffering from a severe case of muscle inflammation (myositis). The researchers noted that risk of developing a very severe form of the autoimmune inflammatory disease is high. The patient who received the CAR T treatment was diagnosed with anti-synthetase syndrome.

Immunity 128

Immunity Immunization Hospitals 128

PhRMA

FEBRUARY 16, 2023

Did you know that insurance companies use middlemen — known as pharmacy benefit managers (PBMs) — to decide what medicines people can get and what people pay out of pocket for those medicines?

119

119

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

Pharmafile

FEBRUARY 8, 2023

Scottish biotech company ScotBio has announced that it has seen “promising initial results” from its attempts to extract a cure for the common cold from algae. The Livingston-based company is assessing how waste molecules from spirulina, an algae often consumed as a superfood, could be used as a cure for the common cold, COVID-19 and various other viruses.

Communication 117

Communication 117

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

Vaccines 117

Vaccines Immunity Immunization 117

PharmaVoice

FEBRUARY 17, 2023

Jacopo Leonardi’s latest venture is in the burgeoning field of macrophage inhibitors that could target a wide range of cancers.

246

246

European Pharmaceutical Review

FEBRUARY 21, 2023

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabin

Pharmaceutical Companies 129

Pharmaceutical Companies Pharmaceutical Companies Compounding Drug Development 129

PhRMA

FEBRUARY 23, 2023

State legislative sessions across the country are in full swing, and many state officials have made lowering the cost of medicine for patients a top priority. If policymakers are serious about addressing high out-of-pocket costs for patients, they should start by taking steps to finally hold pharmacy benefit managers (PBMs) accountable.

110

110

Pharmafile

FEBRUARY 13, 2023

Mumbai-based pharma company, Sun Pharma, has announced that it is recalling over 34,000 bottles of a generic drug, Diltiazem Hydrochloride, from the US market. The drug is used for treating high blood pressure, angina and some types of irregular heartbeat. This recall follows the FDA’s Enforcement Report, which saw “failed impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Communication 115

Communication 115

Advertisement

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

Pharmacy Management

Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

Vaccines 115

Vaccines Communication 115

STAT

FEBRUARY 1, 2023

A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h

364

364

PharmaVoice

FEBRUARY 27, 2023

Staffing shortages are causing inefficiencies in clinical trials, but one leading CRO is finding ways to adapt.

264

264

Pharma Times

FEBRUARY 21, 2023

Final draft guidance from NICE ensures people at highest risk will have access to COVID-19 therapies

141

141

PhRMA

FEBRUARY 28, 2023

For over a decade, Rare Disease Day has been celebrated on February 28 to raise awareness and generate change for the more than 30 million patients in the U.S. living with a rare disease. This year’s Rare Disease Day is particularly special because this year also marks the 40 th anniversary of the Orphan Drug Act (ODA), allowing us to celebrate all the progress that’s come to patients because of it.

108

108

Pharmafile

FEBRUARY 7, 2023

AstraZeneca has announced that its drug, Forxiga, has been approved in the EU for the treatment of symptomatic chronic heart failure. This follows an approval from the EMA’s Committee for Medicinal Products for Human Use in December. The drug is already approved in the EU for the treatment of type 2 diabetes as well as chronic kidney disease. It has also received regulatory approvals in Britain, Japan and Turkey, as well as the US and now the EU.

Diabetes 105

Diabetes Communication 105

Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

105

105

STAT

FEBRUARY 16, 2023

Matt Fitzgerald used to bike up and down 3,500 feet through the Santa Ana Mountains on three-hour rides just for fun. Now, nine months after being infected with SARS-CoV-2, the virus that causes Covid-19, he can’t muster walking on flat surfaces for 20 minutes without days of exhaustion. “My long Covid life remains terrifying,” he told me.

360

360

PharmaVoice

FEBRUARY 22, 2023

Kristen Fortney, CEO of BioAge Labs, wants to improve the human life span by focusing on the human health span.

246

246

Pharma Times

FEBRUARY 23, 2023

Next phase of Newel Health’s digital therapeutics solution for Parkinson’s disease gains vital grant

131

131

The Guardian - Pharmaceutical Industry

FEBRUARY 13, 2023

Appetite suppressant Wegovy, popular with celebrities, seen as breakthrough treatment but not permanent remedy Weekly weight-loss jabs that are popular with celebrities will soon be made available through high street chemists in England, despite controversy over their use. Many people struggle to tackle obesity through diet and exercise alone as they often find they regain the weight that they lose.

100

100

European Pharmaceutical Review

FEBRUARY 13, 2023

Tokyo researchers have developed a new analytical platform based on liquid chromatography, mass spectrometry and software analysis that quantifies the structure of messenger RNA (mRNA)-based medicines. The method is an important innovation for quality control ( QC) in production lines. The platform can elucidate mRNA sequences while quantifying ‘capping’ at one end of the molecule and the integrity of the tail on the other, all vital in mRNA pharmaceuticals.

Immunity 102

Immunity Immunization Labelling Vaccines 102

Pharmaceutical Technology

FEBRUARY 7, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

Vaccines 105

Vaccines Immunity Immunization 105

STAT

FEBRUARY 16, 2023

Akin Akinc was scouring his email spam box last summer, looking for a missing message, when he stumbled across an unexpected email from a quite recognizable name: Feng Zhang. Zhang, one of the leading scientists in the groundbreaking field of genetic editing, had reached out two days prior to discuss a new company he was working on. Since helping to discover CRISPR-Cas9 — often referred to as molecular scissors that can cut into the genome and edit DNA — Zhang has founded at least

342

342

PharmaVoice

FEBRUARY 28, 2023

With more gene therapies headed to market, novel payment methods are emerging from regulators and academia.

246

246

Pharma Times

FEBRUARY 17, 2023

Research concerning candidate VLA15 has been discontinued across certain trial sites

Vaccines 141

Vaccines 141

Pulses

FEBRUARY 28, 2023

By: Jaclyn Boyle, MS, MBA, BCACP and Jonathan Lang, PharmD Candidate 2023 With the technological advances of today’s age, will students lose the ability to communicate face to face (F2F)? The newly revised AACP Curriculum Outcomes and Entrustable Professional Activities (COEPA) stress the importance of communication. COEPA 2.2 states that students should “actively engage, listen, and communicate verbally, nonverbally, and in writing when interacting with or educating an individual, group,

Communication 98

Communication Hospitals 98

European Pharmaceutical Review

FEBRUARY 21, 2023

Included in this issue of European Pharmaceutical Review : FOREWORD Accelerating drug development David Elder, David P Elder Consultancy RAMAN SPECTROSCOPY Shining a light on Raman for microbiological analysis Tim Sandle, Bio Products Laboratory LIMS Overcoming barriers to capturing data in a laboratory Samantha Kanza, University of Southampton ENVIRONMENTAL MONITORING Endotoxin trends: sustainability, automation and beyond Miriam Guest, AstraZeneca UK REGULATORY INSIGHT UPC opt-out – a strateg

Drug Development 102

Drug Development 102

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD.

105

105

STAT

FEBRUARY 28, 2023

Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Click on each matchup for a short summary of each school’s pioneering research. Then pick your favorites. Help us crown a champ!

327

327

PharmaVoice

FEBRUARY 15, 2023

After a rocky year, Passage Bio’s CEO is focused on helping the rare disease specialist bounce back.

246

246

Med Ed 101

FEBRUARY 26, 2023

I’ve followed the NAPLEX exam since I graduated in 2009. The NAPLEX was relatively easy from my experience and the experience of many of my classmates. The pass rate that year was an indicator that the NAPLEX was not very difficult. That is not the case anymore. Just looking at the California Board of Pharmacy […] The post What The NAPLEX 2022 Pass Rate Tells Us About 2023 appeared first on Med Ed 101.

98

98

PharmExec

FEBRUARY 22, 2023

Sermo and LiveWorld survey of 50+ pharma marketers and 200+ physicians finds that social media plays a major role in influencing perceptions of medications, prescribing Habits, ongoing medical education and professional networking.

98

98

Outsourcing Pharma

FEBRUARY 22, 2023

Father and software engineer, Vincent Keunen combined his personal experience of leukemia and his son's bone cancer with his professional skills to provide all patients with a tool to manage their health information on their smartphone.

98

98

Pharmaceutical Technology

FEBRUARY 14, 2023

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Kidney disorder treatm

Diabetes 105

Diabetes Pharmaceutical Companies Pharmaceutical Companies Vaccines 105