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Last chance to register for TransPerfect Life Sciences’ C3 Summit!

SHAPING THE FUTURE OF eCOA/ePRO We have witnessed a rapid and dramatic migration from paper to electronic COA/PRO in the past few years. TransPerfect Life Sciences’ C3 Summit brings to you virtual sessions on how the paper to digital migration is evolving, the use and application of eCOA migration technology, and setting up successful eCOA solutions. Register now and …

Last chance to register for TransPerfect Life Sciences’ C3 Summit! Read More »

KOL Digital Listening – 3 Things you need to understand today

Finding and analyzing content can be challenging. Many teams start with searching Google, Twitter, LinkedIn, and other digital sources. Having more sophisticated methods for gathering and analyzing digital insights is important. There are three keys to effective KOL digital listening: 1: Look Beyond Social Media There are millions of digital sources world-wide. Social media is …

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WTF Health: Inside FarmboxRx’s Groundbreaking Work in SNAP/EBT Benefits to “Eradicate Food Deserts Overnight”

BY JESSICA DaMASSA, WTF HEALTH HUGE news on the “food-as-medicine” front for Medicaid/Medicare Advantage beneficiaries! Now, they can get fresh fruits and veggies delivered directly to their doorsteps and they can pay for them using their SNAP/EBT benefits. FarmboxRx is behind this first-of-its-kind partnership with the U.S. Department of Agriculture, and here to talk through …

WTF Health: Inside FarmboxRx’s Groundbreaking Work in SNAP/EBT Benefits to “Eradicate Food Deserts Overnight” Read More »

Inside FarmboxRx’s Groundbreaking Work in SNAP/EBT Benefits to “Eradicate Food Deserts Overnight”

By JESSICA DaMASSA, WTF HEALTH HUGE news on the “food-as-medicine” front for Medicaid/Medicare Advantage beneficiaries! Now, they can get fresh fruits and veggies delivered directly to their doorsteps and they can pay for them using their SNAP/EBT benefits. FarmboxRx is behind this first-of-its-kind partnership with the U.S. Department of Agriculture, and here to talk through …

Inside FarmboxRx’s Groundbreaking Work in SNAP/EBT Benefits to “Eradicate Food Deserts Overnight” Read More »

Ms. Olabunbi Underwent Unilateral Hip Replacement in Indraprastha Apollo Hospital, India

Introduction A young 23-year-old woman, Aderiyike Olabunbi, traveled from Nigeria with her mother to get treated for her fractured hip. After suffering from an accident she fractured her hip. That is when she got in touch with professionals at MediGence who guided her and her mother through the entire process. Her consultations were arranged through …

Ms. Olabunbi Underwent Unilateral Hip Replacement in Indraprastha Apollo Hospital, India Read More »

Digital Engagement in Pharma: Staying Ahead of Patient Needs to Shape Better Outcomes

Conduent recently participated at CBI PAP (Patient Assistance & Access Programs) Conference – a virtual event where pharma stakeholders collaborate on programs and policies for better patient outcomes. While there, I had the opportunity to discuss some of the ways pharma can make patient engagement easier in an increasingly digital world. Creating a better experience …

Digital Engagement in Pharma: Staying Ahead of Patient Needs to Shape Better Outcomes Read More »

THCB Gang Episode 71, Nov 4 1pm PT – 4pm ET

Joining Matthew Holt (@boltyboy) on THCBGang Thursday are fierce patient activist Casey Quinlan (@MightyCasey); cardiologist & provocateur Anish Koka (@anish_koka); patient activist, author & entrepreneur Robin Farmanfarmaian (@Robinff3); and THCB regular writer Kim Bellard (@kimbbellard). You can see the video below but if you’d rather listen to the episode, the audio is preserved as a weekly …

THCB Gang Episode 71, Nov 4 1pm PT – 4pm ET Read More »

#Healthin2Point00, Episode 240|Tebra, Notable, Wellinks, Aktiia, and Enlace Health

Today on Health in 2 Point 00, Jess and I talk briefly about Frontiers Health – frontiers.health – a digital health company with a deep therapeutics focus. Kareo and Patient Pop merge to form Tebra and get $65 million dollars from a PE firm. A notable raise from Notable, $100 million in a Series B …

#Healthin2Point00, Episode 240|Tebra, Notable, Wellinks, Aktiia, and Enlace Health Read More »

WTF Health: Included Health’s CEO Owen Tripp on Grand Rounds, Doctor-on-Demand Merger & New Name

By JESSICA DaMASSA, WTF Health A sign of effective ‘merging-and-acquiring’ among innovative healthcare companies? How about a new brand-name? The company known as “Grand Rounds Health and Doctor on Demand,” which merged in March 2021 and quickly acquired LGBTQ+ virtual care company, Included Health, announced that the company would be moving forward as Included Health …

WTF Health: Included Health’s CEO Owen Tripp on Grand Rounds, Doctor-on-Demand Merger & New Name Read More »

#Healthin2Point 00, Episode 236 | HLTH 2021, Oak Street, 23andMe, Babylon Health, and Everlywell

Today on Health in 2 Point 00, Jess and I catch up after HLTH 2021. Some massive deals in Episode 356: Oak Street acquires Rubicon MD for 190 million, 130 in cash; 23andMe acquires Lemonade (a virtual care and drug delivery company) for 400 million – 300 million in stocks and 100 million in cash; …

#Healthin2Point 00, Episode 236 | HLTH 2021, Oak Street, 23andMe, Babylon Health, and Everlywell Read More »

Inside Scoop: Medicaid Mental Health Startup Brave Health Lands $10M

By JESSICA DaMASSA, WTF HEALTH Healthcare startups serving the Medicaid population are FINALLY catching the attention of investors and, this time, it’s for improving access to mental health services. Brave Health’s CEO Anna Lindow and I catch up in person at HLTH 2021 – under a super-secret embargo – to talk about Brave’s $10M Series …

Inside Scoop: Medicaid Mental Health Startup Brave Health Lands $10M Read More »

Cato supports public option?

A white paper from Cannon and Pohida (2021) calls for applying “public option principles” to Medicare. Who would have thought that the Cato Institute would call for a public option? Well in fact, the do not really call for a public option. The proposal should be called introducing a voucher system into Medicare. Under the …

Cato supports public option? Read More »

Piramal Pharma Solutions-Walk-In Interviews for R&D On 23rd October 2021

Piramal Pharma Solutions-Walk-In Interviews for R&D On 23rd October 2021 Job Description Company Profile:  Piramal Pharma Solutions is the Contract Development and Manufacturing arm of Piramal Pharma Ltd., with operations across North America, Europe and Asia. We are a global leader in integrated solutions and offer a unique platform of services across the drug lifecycle …

Piramal Pharma Solutions-Walk-In Interviews for R&D On 23rd October 2021 Read More »

Patient Testimonial | Mr. Abubakaihas Underwent Sleeve Gastrectomy Surgery in NMC Hospital, Dubai

Introduction Abubakaihas, 40, a resident of Nigeria, was extremely conscious of his body contour. He was concerned about his increasing body weight, which affected his normal life. His obesity caused several other issues like back pain, increased blood pressure, and fatigue. He tried dieting and exercise and even consulted a dietician to lose his weight, …

Patient Testimonial | Mr. Abubakaihas Underwent Sleeve Gastrectomy Surgery in NMC Hospital, Dubai Read More »

Snickerdoodle Pumpkin Loaf using Quest Protein Cookies

A delicious Quest Snickerdoodle Protein Cookie needs no partner in crime to steal your heart. But look what it can accomplish with a little help from Quest Vanilla Milkshake Protein Powder! These two great tastes team up with some seasonal spices for the Questified Pumpkin Loaf of your dreams. Check […]

PharmaShots Weekly Snapshots (October 04 – 08, 2021)

AbbVie’s Rinvoq (upadacitinib) Receives the Health Canada Approval for the Treatment of Moderate to Severe Atopic Dermatitis Published: Oct 8, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, Health Canada, Approval, Atopic Dermatitis Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients Published: Oct 8, 2021 | Tags: …

PharmaShots Weekly Snapshots (October 04 – 08, 2021) Read More »

Reworking the Recipe: Expanding Customer-Facing Medical Teams Beyond Medical Science Liaisons

Pharma continues to evolve in the way Medical Affairs engages with Healthcare Professionals (HCPs) and Key Opinion Leaders (KOLs). From a Medical Affairs perspective, the global upheaval of 2020-21 highlighted the importance of targeting the best stakeholders, knowing exactly how team members are engaging with those stakeholders, and maximizing the effectiveness of field-based medical teams. …

Reworking the Recipe: Expanding Customer-Facing Medical Teams Beyond Medical Science Liaisons Read More »

Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC

Shots: The approval is based on the P-I/II trial evaluating Exkivity (160 mg) in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior Pt-based therapy The results demonstrated ORR (28%) as assessed by IRC & 35% as per investigator, m-DoR (17.5mos.), m-OS (24mos.), and m-PFS (7.3mos.) as per IRC Exkivity is a TKI inhibitor …

Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC Read More »

Healing at Home: Answering the $30,000 Question

By DAWN CARTER If you’ve been working remotely for the past year, would a $30,000 raise entice you back into the office? In a recent survey of 3,000 workers at dozens of large US companies, the vast majority of respondents said they would forego the hefty raise if they could keep working in their pajamas. …

Healing at Home: Answering the $30,000 Question Read More »

Encube Ethicals – Openings for Executive/ Senior Executive in Quality Control-Apply Now

Encube Ethicals – Openings for Executive/ Senior Executive in Quality Control-Apply Now Job Description We at Encube are looking for Executive/ Senior Executive in Quality Control Department with hands on experience in handling HPLC, GC,UV, Dissolution. The job will be based in Goa Location. Department: QC Designation: Executive/ Senior Executive Qualification: M.Sc (Chemistry) Experience: 06-08 years Location: Goa Mail your …

Encube Ethicals – Openings for Executive/ Senior Executive in Quality Control-Apply Now Read More »

PharmaShots Interview: Revolo’s Jonathan Rigby Shares Insights on the ‘1104 for Eosinophilic Esophagitis

In an interview with PharmaShots, Jonathan Rigby, Group Chief Executive Officer at Revolo Biotherapeutics shared his views on the unique mechanism of ‘1104 and discuss the plan of the company’s clinical studies. Shots: Revolo reported the US FDA’s approval to initiate a P-II clinical trial evaluating the safety and efficacy of ‘1104 in adults with …

PharmaShots Interview: Revolo’s Jonathan Rigby Shares Insights on the ‘1104 for Eosinophilic Esophagitis Read More »

Capability measures to value health interventions for kids

Traditional cost-effectiveness measures measures treatment value based on how it affects your health. Health is often decomposed into longevity (i.e., survival) and quality of life while alive. However, Nobel laureate Amartya Sen argued that improvements in one’s life should be based on capabilities (a.k.a. opportunities, freedoms, advantages) to perform desired tasks rather than more abstract …

Capability measures to value health interventions for kids Read More »

Sorrento to License Dyadic’s DYAI-100 and C1 Technology for Protein-Based Coronavirus Vaccines and Therapeutics

Shots: Dyadic to receive $10M up front in cash & stock and ~$4M in reimbursements for pre/ clinical development costs for DYAI-100 vaccine & ~ $33M in milestone along with royalties following commercialization Sorrento acquire exclusive rights to use Dyadic’s C1 technology to develop and commercialize vaccines, Abs, protein therapeutics, and diagnostics for COVID-19, including …

Sorrento to License Dyadic’s DYAI-100 and C1 Technology for Protein-Based Coronavirus Vaccines and Therapeutics Read More »

Mankind Pharma Limited- Walk-In Drive for QC/  Microbiology / Quality Assurance On 14th & 15th August 2021

Mankind Pharma Limited- Walk-In Drive for QC/  Microbiology / Quality Assurance On 14th & 15th August 2021 Job Description We are looking for young and dynamic personnel from Pharma background with proven track records, who have exposure to advance market operations (USFDA, TGA, EDQM, MHRA, etc) for Tablets, Capsules, Sterile Injectable USFDA Approved Formulation Unit …

Mankind Pharma Limited- Walk-In Drive for QC/  Microbiology / Quality Assurance On 14th & 15th August 2021 Read More »

Cost of drug utilization management is over $90 billion per year

Many of us who are patients have the unpleasant experience of navigating the complex world of drug utilization management. This includes determining what formulary tier a drug will be on, if there are any prior authorization requirements and what our copay will be. The burden also falls on physicians in that they need to justify …

Cost of drug utilization management is over $90 billion per year Read More »

Back-End Problems Continue to Haunt Home Health Agencies

Managing back-end operations is arguably as paramount to a home health agency’s success as the patient-facing, clinical aspects of the business. Even so, that task has often been put on the back-burner in the past. But with the onset of no-pay RAPs, the Patient-Driven Groupings Model (PDGM), the Review Choice Demonstration (RCD) in select states …

Back-End Problems Continue to Haunt Home Health Agencies Read More »

PharmaShots Interview: Prime Therapeutics’ Kelly Pokuta and April Kunze Share Insight on Medical Drug Management Program

In an interview with PharmaShots, Kelly Pokuta, Vice President of Pharmaceutical Trade Relations, and April Kunze, Senior Director, Clinical Formulary Development & Trend Management Strategy at Prime therapeutics share their views on the MedDrive as a first-of-its-kind medical drug management program uniquely aligned with Blue Plan clients. Shots: Prime introduced the first-of-its-kind medical drug management …

PharmaShots Interview: Prime Therapeutics’ Kelly Pokuta and April Kunze Share Insight on Medical Drug Management Program Read More »

Outlook Reports Results of ONS-5010 / Lytenava (bevacizumab-vikg) in P-III NORSE TWO Trial for the Treatment of Wet AMD

Shots: The P-III NORSE TWO trial evaluates the safety & efficacy of ONS-5010 / Lytenava vs ranibizumab in 228 patients with wet AMD across 39 clinical trial sites in the US for 12mos. The trial met 1EP & 2EPs i.e proportion of patients who gain at least 15 letters in the BCVA & mean change …

Outlook Reports Results of ONS-5010 / Lytenava (bevacizumab-vikg) in P-III NORSE TWO Trial for the Treatment of Wet AMD Read More »

test

Quironsalud Madrid University Hospital Madrid,Spain Quironsalud Madrid University Hospital is considered to be a benchmark for other private hospitals in the Madrid region. Top-level professionals, cutting edge technology and personalized attention and the three pillars that comprise the hospital’s healthcare philosophy. The hospital complex is spread across a vast area of 54,000 square meters. The …

test Read More »

PerkinElmer to Acquire BioLegend for $5.25B

Shots: PerkinElmer to acquire BioLegend for ~$5.25B in cash and stock transaction. The acquisition is expected to close by the end of 2021 The acquisition will allow PerkinElmer to build its growth in areas such as clinical diagnostics and food safety testing With the acquisition, BioLegend’s San Diego, California-based campus will become the global center …

PerkinElmer to Acquire BioLegend for $5.25B Read More »

Home Health Veterans Windley, Strange Hoping to Take Aveanna Above and Beyond $2 Billion

Rod Windley and Tony Strange have been in business with each other for decades. They continue to be partners today as the chairman and CEO, respectively, of Aveanna Healthcare (Nasdaq: AVAH). From The Healthfield Group Inc. and Gentiva Health Services, Kindred at Home’s predecessor, to Aveanna, Windley and Strange have helped build a handful of …

Home Health Veterans Windley, Strange Hoping to Take Aveanna Above and Beyond $2 Billion Read More »

Health Biotech Ltd-Walk-In Interviews for QA/ QC On 19th to 23rd July 2021

Health Biotech Ltd-Walk-In Interviews for QA/ QC On 19th to 23rd July 2021 Job Description Company Profile:  Health Biotech Ltd, We are reputed WHO, GMP, ISO 9001:2008 pharma company, having global presence, manufacturing of injectables, liquid syrups, dry syrups, eye / ear / nasal drops, pre-filled syringes and non sterile / sterile ointments, tables, Capsules. …

Health Biotech Ltd-Walk-In Interviews for QA/ QC On 19th to 23rd July 2021 Read More »

ViewPoints Interview: bluebird bio’s Rich Colvin Shares Insights on the Skysona to Treat Early Cerebral Adrenoleukodystrophy

In an interview with PharmaShots, Rich Colvin, M.D., Ph.D., Interim Chief Medical Officer at bluebird bio shares his views on the Skysona and its working on CALD patients. Shots: If granted marketing authorization, Skysona would be the first approved one-time gene therapy for CALD which is a rare neurogenerative disease with typically childhood onset The …

ViewPoints Interview: bluebird bio’s Rich Colvin Shares Insights on the Skysona to Treat Early Cerebral Adrenoleukodystrophy Read More »

Vital Pharma -Walk-In Interviews for Production/ QA/ QC/ AR&D / Stores/ Maintenance Dept. On July’ 2021

Vital Pharma -Walk-In Interviews for Production/ QA/ QC/ AR&D / Stores/ Maintenance Dept. On July’ 2021 Job Description Interested Candidates are please Share your Update CV below I’d Email:   [email protected] HR:  9666977644 Vital Pharma -Walk-In Interviews for Production/ QA/ QC/ AR&D / Stores/ Maintenance Dept. On July’ 2021

Matthew’s health care tidbits

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt In this week’s health care tidbits, a little …

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Walmart Store List: Candy Bites

**Walmart locations listed in alphabetical order by State** We highly suggest you check Walmart.com or call any store ahead of time to guarantee availability. Store Nbr City State Format 301 Gadsden Alabama WM SC 316 Attalla Alabama WM SC 660 Muscle Shoals Alabama WM SC 661 Athens Alabama WM SC 670 Cullman […]

Hard Thinking About Protein Degradation and Bifunctional Molecules

This paper (open access) is not going to be to everyone’s taste, but the people who are working in its area – and there’s an ever-increasing number of them – will want to read it closely. It’s a close look at the red-hot fields of targeted protein degradation and “molecular glues”, and for those who aren’t …

Hard Thinking About Protein Degradation and Bifunctional Molecules Read More »

Macleods Pharma- Requirement for Production/ Quality Control Dept. -Apply Now

Macleods Pharma- Requirement for Production/ Quality Control Dept. -Apply Now Job Description Openings for Production We are looking for experienced professionals in Production (API) Department for our API Plant, Sarigam (Vapi), Gujarat Location. Department: Production (API) Department Experience: 03-8 years Educational Qualification: BE/B.Tech.(Chemical)/ B.Sc./ M.Sc. Location: Vapi Skill Set: Relevant experience in API/ Intermediate Manufacturing industry. Interested Candidates May send …

Macleods Pharma- Requirement for Production/ Quality Control Dept. -Apply Now Read More »

Walmart Store List: Hero Bars

**Walmart locations listed in alphabetical order by State** We highly suggest you check Walmart.com or call any store ahead of time to guarantee availability. Store Nbr City State Format 301 Gadsden Alabama WM SC 316 Attalla Alabama WM SC 660 Muscle Shoals Alabama WM SC 661 Athens Alabama WM SC 670 […]

THCB Gang Episode 56 – Thurs June 3, 1pm PT-4pm ET

Episode 56 of “The THCB Gang” will be Thursday, June 3. Matthew Holt (@boltyboy) will be joined by regulars: medical historian Mike Magee (@drmikemagee), THCB regular writer Kim Bellard (@kimbbellard) and health futurist Jeff Goldsmith; We are hoping that WTF Health host & Health IT girl Jessica DaMassa (@jessdamassa) will sneak in later after she’s finished …

THCB Gang Episode 56 – Thurs June 3, 1pm PT-4pm ET Read More »

Matthew’s health care tidbits

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet!–Matthew Holt In this week’s health care tidbits, we’re discussing hedge …

Matthew’s health care tidbits Read More »

Links

Rise in mental health tele-visits. Inequality, conspicuous consumption and health expenditures. Treating serious illness at home. Why do scientists lie? BMI and income.

THCB Gang Episode 55, Thursday May 20

Episode 55 of “The THCB Gang” will be live-streamed on Thursday, May 20 at 1pm PT — 4PM ET. Matthew Holt (@boltyboy) will be joined by regulars: futurists Ian Morrison (@seccurve) & Jeff Goldsmith; patient safety expert and all around wit Michael Millenson (@MLMillenson); and policy & tech expert Vince Kuraitis (@VinceKuraitis)

This is a simple post

This is a simple post This is post body content. This is post body content.This […] The Doctor Weighs In

Establishing trust in clinical trials

A positive participant experience underpins the success of any clinical trial. Leverage three strategies to help establish trust between participants and study staff. Read the blog by @advarra. https://www.pharmavoice.com/blog/engage-participants-trial/ The post Establishing trust in clinical trials appeared first on PharmaVOICE.

Proton Therapy – Ultimate Guide for Patients

Proton therapy is expected to be the next big thing in future of medical science. The advanced mode of treatment deserves all the hype it garners as it is the result of intense research and thorough study of innumerable researchers and doctors all across the globe. The concept of proton therapy was proposed by Robert …

Proton Therapy – Ultimate Guide for Patients Read More »

MSN Laboratories Pvt. Ltd. -Walk-In Drive (15 Openings) for Freshers & Experienced -R&D Dept. API Division On 24th April 2021

MSN Laboratories Pvt. Ltd. -Walk-In Drive (15 Openings) for Freshers & Experienced -R&D Dept. API Division On 24th April 2021 Job Description Walk-In Drive for B.Sc Chemistry/ M.Sc Fresher’s & Experience in R&D Department API Division- MSN LS-II, Chandampeta(V) Shankarampeta (Mdl.) Position: Junior Executive -Trainee/ Executive Trainee/ Executive Department: Research & Development (R&D-API) Experience: 0 to 5 Years Eligibility Criteria …

MSN Laboratories Pvt. Ltd. -Walk-In Drive (15 Openings) for Freshers & Experienced -R&D Dept. API Division On 24th April 2021 Read More »

Vaccine Efficacy Questions

Next up on the vaccine news front are some concerns about efficacy. In a very surprising statement, Gao Fu (the head of the Chinese Center for Disease Control and Prevention) said at a conference in Chengdu over the weekend that that the protection figures of the Chinese vaccines are “not high”. He called for research …

Vaccine Efficacy Questions Read More »

Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions

The UK’s Drug Safety Research Unit (DSRU) has launched a Global Pharmacovigilance Observatory to help the pharma industry understand why international regions reach different decisions on the use of medicines. The observatory will review and collate pharmacovigilance and drug safety data, analyses, evaluations and decisions made in different countries or regions to help regulators and …

Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions Read More »

New group to tackle data governance and guide digital transformation in pharma

The Pistoia Alliance, a global, not-for-profit alliance advocating for greater collaboration in life sciences R&D, has launched its Data Governance Community of Interest (CoI). The CoI was set up after a roundtable discussion assessing industry priorities, attended by professionals from pharma companies such as AbbVie, Bayer, Bristol Myers Squibb, Novo Nordisk, Pfizer, Roche and Sanofi, …

New group to tackle data governance and guide digital transformation in pharma Read More »

GSK Consumer Healthcare to incorporate paper bottles into its packaging

GlaxoSmithKline Consumer Healthcare (GSKCH) has joined the Pulpex paper bottle partner consortium and will explore incorporating recyclable paper bottles into its packaging. The partnership is part of GSKCH’s commitment for all consumer product packaging to be recyclable or reusable, including eliminating all problematic and unnecessary plastics, where quality and safety permits, by 2025. Pulpex Limited …

GSK Consumer Healthcare to incorporate paper bottles into its packaging Read More »

Dependency vs. Addiction: How to Know If You’ve Crossed the Line

Dependency vs. Addiction: How to Know If You’ve Crossed the Line With so much attention focused on the opioid addiction crisis, many doctors are reluctant to prescribe prescription pain medications and many people are reluctant to take them. The fear of becoming addicted is often perpetuated by widespread media coverage of how “addictive” medications like …

Dependency vs. Addiction: How to Know If You’ve Crossed the Line Read More »

Androgen Receptors for COVID-19

There’s a report of an interesting small-molecule drug effort against the coronavirus that seems to have produced rather significant results. The idea goes back to effects that were noticed last year – for example, in this population-based study from Italy. It’s been known since the early days of the pandemic that males were overall more …

Androgen Receptors for COVID-19 Read More »

Get the latest news and views for how to drive healthcare forward

IQVIA has a new LinkedIn page, and they want you to be part of the conversation about moving health care forward. It promises to be an outstanding source for the latest news, insights, and updates. Be part of this dedicated community. http://bit.ly/IQVIA-LI The post Get the latest news and views for how to drive healthcare …

Get the latest news and views for how to drive healthcare forward Read More »

Home Health Giants Double Down on Diversion, as Nursing Home Numbers Normalize

Acute and post-acute patient volumes started to normalize in the early part of 2021, with hospitals, skilled nursing facilities (SNFs) and home health providers all hovering around their 2019 baselines. The accelerated rollout of COVID-19 vaccines is largely responsible for the newfound stability, particularly in the SNF space. Following millions of inoculations across the U.S., …

Home Health Giants Double Down on Diversion, as Nursing Home Numbers Normalize Read More »

Molnupiravir: Last of the Small-Molecule Coronavirus Hopes?

A lot of people have been wondering about what’s up with a small-molecular antiviral compound that’s been in the news on and off during the pandemic. That’s molnupiravir, below, also known as EIDD-2801 and MK-4482. It has all those numbers because it has some history behind it. The compound was discovered at Emory in the …

Molnupiravir: Last of the Small-Molecule Coronavirus Hopes? Read More »

Early March Vaccine Thoughts

Some thoughts about the current vaccine trials and data, some of which are probably obvious, but which might be worth bringing together: First, as many have been mentioning, it’s tempting but quite difficult to compare the vaccines (and vaccine candidates) head-to-head by looking at their phase III data. I would only feel safe doing this …

Early March Vaccine Thoughts Read More »

A Malaria Vaccine Candidate

This story has been passed around a lot the last few days, and I’ve had several people ask me what I’ve thought of it. It’s on a really interesting possibility for a malaria vaccine, and part of the narrative hook is that it’s using mRNA technology, which is about as attention-getting a topic these days …

A Malaria Vaccine Candidate Read More »

Vetiver

In my experience, most organic and medicinal chemists are always ready to hear about the latest results in two branches of the science: things that explode and things with weird smells. Maybe we are in our way “singularly in touch with the primitive promptings of humanity”, as Captain Grimes says in Decline and Fall (although …

Vetiver Read More »

The J&J Vaccine at the FDA

The briefing documents are out at the FDA site for tomorrow’s hearing on the J&J vaccine. Here’s a summary at STAT from Matthew Herper and Helen Branswell, and I agree with their take: overall, the numbers look good. Update: here’s a good Twitter thread from Hilda Bastian, and here’s one from Eric Topol. Like every …

The J&J Vaccine at the FDA Read More »

COVID-19 excess mortality by race

How did COVID-19 affect mortality rates and how did that vary by racial and ethnic groups? Using January 2011 – April 2020 data from the Census Bureau’s version of the Social Security Administration’s Numerical Identification (Numident) database, a paper by Polyakova et al. (2021) find significantly higher all-cause excess mortality rates for minority groups, particularly …

COVID-19 excess mortality by race Read More »

Cancer and Gene Therapy

There’s news today that Bluebird has suspended its gene therapy work on sickle cell disease because of two cases of cancer in its treatment population. Another had been reported in 2018, so that takes us to two cases of myelodysplastic syndrome and one case of myeloid leukemia (which can be a sequel of MDS in …

Cancer and Gene Therapy Read More »

GLP-1 and Obesity

Let’s have a look at a paper that came out recently in the New England Journal of Medicine. It shows strong results in a therapeutic area that a lot of people have spent a lot of effort on: obesity. I’ve been kicking around the idea of reviewing the history of anti-obesity drug discovery, but it’s …

GLP-1 and Obesity Read More »

Novel ionic liquid enables uniform chemotherapy delivery in solid tumours

In preclinical studies, injection of a novel ionic liquid formulation (“locally active agent for tumour treatment and eradication” or LATTE) allowed uniform delivery of a chemotherapy drug in solid tumours. According to the study’s senior author, Dr Rahmi Oklu, a vascular and interventional radiologist at Mayo Clinic and director of Mayo Clinic’s Minimally Invasive Therapeutics …

Novel ionic liquid enables uniform chemotherapy delivery in solid tumours Read More »

Antibody-Dependent Enhancement and the Coronavirus Vaccines

I’m getting a lot of queries about antibody-dependent enhancement these days, and I can only assume that’s because there’s a lot of talk about this making the rounds of various social media platforms. Many of the people who are contacting me sound a lot more worried than I would have thought, so that prompts me …

Antibody-Dependent Enhancement and the Coronavirus Vaccines Read More »

First immunotherapy for advanced basal cell carcinoma approved in US

The US Food and Drug Administration (FDA) has approved the first immunotherapy for patients with advanced basal cell carcinoma (BCC). Libtayo® (cemiplimab-rwlc), a PD-1 inhibitor, was also granted accelerated approval in metastatic BCC. “Today’s FDA approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma,” remarked Dr Karl Lewis, Professor …

First immunotherapy for advanced basal cell carcinoma approved in US Read More »

Semaglutide: “a significant advance in the treatment of obesity,” say scientists

A third (35 percent) of obese patients treated with semaglutide in a large-scale international trial lost at least a fifth of their total bodyweight within 68-week. According to the researchers, the results are a gamechanger for improving the health of people with obesity and could play a major part in helping reduce the impact of …

Semaglutide: “a significant advance in the treatment of obesity,” say scientists Read More »

FDA approves emergency use of Lilly’s COVID-19 antibody combination

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age or older weighing at least 40) who are at high risk for progressing to severe COVID-19. The indication …

FDA approves emergency use of Lilly’s COVID-19 antibody combination Read More »

ViewPoints Interview: ViiV Healthcare’s Duncan Short Shares Insight on PROgress Study Demonstrating that Pre-Visit Survey Can Improve HIV Care

In a recent interview with PharmaShots, Duncan Short, Ph.D., Director of Global Implementation Science at ViiV Healthcare shared his views on the findings of a new study demonstrating how the inclusion of a brief survey focused on patient-reported outcomes (PROs) during doctor’s appointments can improve HIV care. Shots: In the study, people living with HIV were …

ViewPoints Interview: ViiV Healthcare’s Duncan Short Shares Insight on PROgress Study Demonstrating that Pre-Visit Survey Can Improve HIV Care Read More »

Peginterferon-lambda accelerates COVID-19 recovery, finds trial

A new trial suggests a single injection of an experimental antiviral drug, peginterferon-lambda, can significantly sped up the recovery of non-hospitalised patients with COVID-19. In the trial, participants who received peginterferon-lambda were four times more likely to clear the infection within seven days than those on placebo. “People who were treated cleared the virus quickly, …

Peginterferon-lambda accelerates COVID-19 recovery, finds trial Read More »

FDA approves third gene therapy for large B-cell lymphoma

Breyanzi (lisocabtagene maraleucel), a chimeric antigen receptor (CAR) T cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or relapsed, after at least two other types of systemic treatment has been approved by the US Food and Drug Administration (FDA). According to the agency, Breyanzi …

FDA approves third gene therapy for large B-cell lymphoma Read More »

NICE recommends treatment for non-squamous, non-small cell lung cancer

The UK National Institute of Health and are excellence (NICE) has published draft guidance approving Keytruda (pembrolizumab) with pemetrexed and platinum chemotherapy, to treat patients with non-squamous, non-small cell lung cancer (NSCLC). The treatment will now be available for patients on the UK National Health Service (NHS).  The draft guidance means pembrolizumab with pemetrexed and …

NICE recommends treatment for non-squamous, non-small cell lung cancer Read More »

J&J submits COVID-19 vaccine data to FDA for emergency authorisation

Johnson & Johnson (J&J) has announced that Janssen has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The company’s EUA submission is based on topline efficacy and safety data from the Phase III ENSEMBLE clinical trial, demonstrating that the …

J&J submits COVID-19 vaccine data to FDA for emergency authorisation Read More »

Intranasal influenza vaccine produces strong immune response, Phase I study shows

An experimental single-dose, intranasal influenza vaccine was safe and produced a durable immune response, a Phase I study has shown.  The investigational vaccine, called Ad4-H5-VTN, is a recombinant, replicating adenovirus vaccine designed to spur antibodies to haemagglutinin, a protein found on the surface of influenza viruses that attaches to human cells. The investigational vaccine was …

Intranasal influenza vaccine produces strong immune response, Phase I study shows Read More »

Oxford AstraZeneca Data, Again

We have some more data to mull over with the Oxford/AstraZeneca vaccine. The situation so far has been pretty confused, with various efficacy numbers appearing from different people in different venues. It’s fair to say that the rollout of the clinical data has not gone smoothly, and that it’s done the effort no favors. As …

Oxford AstraZeneca Data, Again Read More »

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve… The post The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA appeared first on DrugPatentWatch – Make Better Decisions.

NICE recommends Beovu (brolucizumab) for treatment of wet AMD

The UK National Institute for Health and Care Excellence (NICE) has issued final guidance, also known as Technology Appraisal Guidance (TAG), recommending Beovu® (brolucizumab) as an option in the National Health Service (NHS) for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults.  According to Novartis, which produces the drug,  the guidance was based on findings from the Phase III HAWK and …

NICE recommends Beovu (brolucizumab) for treatment of wet AMD Read More »

Phase III trial shows Sputnik V COVID-19 vaccine is 91.6 percent effective

An interim analysis of data from the Phase III trial of the Sputnik V COVID-19 vaccine from Russia (Gam-COVID-Vac) suggests that a two-dose regimen of the adenovirus-based vaccine offers 91.6 percent efficacy against symptomatic COVID-19. The preliminary findings are based on analysis of data from nearly 20,000 participants, three-quarters of whom received the vaccine and one …

Phase III trial shows Sputnik V COVID-19 vaccine is 91.6 percent effective Read More »

Myths of Vaccine Manufacturing

In the last few days, the question of why more drug companies haven’t been enlisted for vaccine production has come up. It’s mostly due to this tweet: The problem is, as far as I can see, this is simply wrong. There are not “dozens of other pharma companies” who “stand ready” to produce these mRNA …

Myths of Vaccine Manufacturing Read More »

COVID-19 clinical trials have risen by 639 percent, says report

According to a new report, there has been a 639 percent increase in the number of COVID-19 clinical trials worldwide, from 549 COVID-19 clinical trials in early April 2020 to over 4,000 in January 2021. Of this figure, 762 trials are taking place in the US – a figure greatly outnumbering activity in other countries, …

COVID-19 clinical trials have risen by 639 percent, says report Read More »

EMA initiates rolling review of Regeneron’s COVID-19 mAb

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a ‘rolling review’ of data on REGN-COV2 antibody combination (casirivimab/imdevimab) for the treatment and prevention of COVID-19. The treatment is being co-developed by Regeneron Pharmaceuticals and Roche. The CHMP’s decision to start the rolling review is based on preliminary results from a study that indicate …

EMA initiates rolling review of Regeneron’s COVID-19 mAb Read More »

Screening, Within and Without

So I’m a small-molecule drug discovery person at heart, since I started out as a synthetic organic chemist. Talking about vaccines and antibodies nonstop is a bit of a strain, then, because immunology is full of stuff that’s rather far removed from good ol’ small-molecule ligands. Actually immunology eventually wears out everyone. Even immunologists. It …

Screening, Within and Without Read More »

J&J COVID-19 vaccine shows success in interim analysis of Phase III trial

An interim analysis of Phase III clinical trial data has shown that the investigational COVID-19 vaccine developed by Janssen Pharmaceuticals, a division of Johnson & Johnson (J&J), appears to be safe and effective at preventing moderate and severe COVID-19 in adults. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be …

J&J COVID-19 vaccine shows success in interim analysis of Phase III trial Read More »

AstraZeneca to provide EU with extra nine million doses of COVID-19 vaccine following dispute

According to new reports, AstraZeneca will deliver nine million more doses of its COVID-19 vaccine to the EU in the first quarter of this year, bringing the company’s commitment to the bloc to total of 40 million for the period. As reported in Reuters, AstraZeneca will also start deliveries one week earlier than expected, the President …

AstraZeneca to provide EU with extra nine million doses of COVID-19 vaccine following dispute Read More »

UK Government orders 100 million doses of Valneva COVID-19 vaccine

The UK Government has signed a deal ordering a further 40 million doses of Valneva’s promising COVID-19 vaccine candidate, after an initial order of 60 million doses. The UK Government also retains the option to order over a further 90 million doses between 2023 and 2025.  According to the government, the latest deal will bolster …

UK Government orders 100 million doses of Valneva COVID-19 vaccine Read More »

J&J and Novavax Data

Suddenly we have a lot more vaccine efficacy data to discuss! Yesterday came an announcement from Novavax about trials they’ve been conducting in the UK and in South Africa with their recombinant protein vaccine, and today comes equally anticipated data from J&J (Janssen) on their adenovirus vector candidate. We’ll have a look at the numbers …

J&J and Novavax Data Read More »

PharmaShots Weekly Snapshots (Jan 25- 29, 2021)

Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, Develop, Quantum Algorithm, Drug, Discovery, Development Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Published: Jan 29, 2020 …

PharmaShots Weekly Snapshots (Jan 25- 29, 2021) Read More »

CEPI offers $140 million to support research on COVID-19 vaccines

The Coalition for Epidemic Preparedness Innovations (CEPI) has opened a new funding opportunity, providing up to $140 million, contingent upon the availability of funds, to support the rapid generation of additional clinical research on COVID-19 vaccines. This includes COVID-19 vaccine developers, as well as public health organisations, academic institutions and others who may not be …

CEPI offers $140 million to support research on COVID-19 vaccines Read More »

Sotorasib shows success against non-small cell lung cancer in Phase II trial

In a Phase II trial, sotorasib was shown to provide durable clinical benefit with a favourable safety profile in patients with pre-treated non-small cell lung cancer (NSCLC) who harbour KRAS p.G12C mutations. The CodeBreak 100 trial results validate the CodeBreak 100 Phase I results. Sotorasib is a first-in-class small molecule that specifically and irreversibly inhibits …

Sotorasib shows success against non-small cell lung cancer in Phase II trial Read More »

Vaccine delivered via skin scarification could help fight respiratory diseases

Until very recently, smallpox vaccines were delivered using a technique known as skin scarification, in which the skin is repeatedly scratched with a needle before a solution of the vaccine is applied. Almost all other vaccines today are delivered via intramuscular injection, with a needle going directly into the muscle, or through subcutaneous injection to …

Vaccine delivered via skin scarification could help fight respiratory diseases Read More »

EMA accepts MAA for Oxbryta to treat haemolytic anaemia in sickle cell disease

The European Medicines Agency (EMA) has accepted Global Blood Therapeutics (GBT) marketing authorisation application for Oxbryta® (voxelotor) for the treatment of haemolytic anaemia in sickle cell disease (SCD). According to the company, the EMA has now started its standard review process.  A first-in-class oral, once-daily therapy, Oxbryta directly inhibits haemoglobin polymerisation, the root cause of the …

EMA accepts MAA for Oxbryta to treat haemolytic anaemia in sickle cell disease Read More »

Moderna COVID-19 vaccine successful against emerging variants, study shows

Moderna has announced results from in vitro neutralisation studies of sera from individuals vaccinated with the company’s COVID-19 vaccine showing activity against emerging strains of SARS-CoV-2. According to the company, vaccination with the Moderna COVID-19 vaccine (mRNA-1273) produced neutralising titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and …

Moderna COVID-19 vaccine successful against emerging variants, study shows Read More »

IGV-001 demonstrates success against glioblastoma in Phase Ib trial

The clinical trial results from a Phase Ib study of IGV-001 for patients with newly diagnosed glioblastoma have been published by Imvax.  IGV-001 is a first-in-class personalised immunotherapy that uses the patient’s own tumour cells combined with an antisense molecule to induce a potent immune response. The treatment comprises irradiated autologous glioma cells with an antisense …

IGV-001 demonstrates success against glioblastoma in Phase Ib trial Read More »

AstraZeneca and Care Access Research Collaborate on Decentralized COVID-19 Clinical Trial

What You Should Know: – AstraZeneca and Care Access Research are teaming up to provide decentralized, mobile research site operations for AstraZeneca’s AZD7442 phase III clinical trial in the US. – The Phase III clinical trial called STORM CHASER will assess the safety and efficacy of AZD7442 for post-exposure prophylaxis and pre-emptive treatment in approximately …

AstraZeneca and Care Access Research Collaborate on Decentralized COVID-19 Clinical Trial Read More »

EC approves RINVOQ (upadacitinib) to treat active psoriatic arthritis

AbbVie has announced that the European Commission (EC) has approved RINVOQ (upadacitinib, 15mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA). The treatment will be used in adult patients who have responded inadequately to or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). …

EC approves RINVOQ (upadacitinib) to treat active psoriatic arthritis Read More »

Merck to discontinue development of COVID-19 vaccine candidates

Merck has announced that the company is discontinuing development of its COVID-19 vaccine candidates, V590 and V591. The company now plans to focus its COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 (molnupiravir) and MK-7110. This decision follows Merck’s review of findings from Phase I clinical studies for the vaccines. In …

Merck to discontinue development of COVID-19 vaccine candidates Read More »

Cognizant and XPRIZE Announce Finalists For $500k COVID-19 Pandemic Response Competition

What You Should Know: – Cognizant, a Fortune 200 leader in technology and professional services, recently partnered with XPRIZE on the Pandemic Response Challenge, a global competition aimed at fighting the pandemic and mapping a course for safely reopening societies using artificial intelligence. The challenge began in November 2020 and recently entered its final phase. …

Cognizant and XPRIZE Announce Finalists For $500k COVID-19 Pandemic Response Competition Read More »

Amneal Pharmaceuticals Pvt. Ltd- Walk-In Interviews (50 Openings) for Manufacturing / Quality Control On 31st Jan’ 2021

Amneal Pharmaceuticals Pvt. Ltd- Walk-In Interviews (50 Openings) for Manufacturing / Quality Control On 31st Jan’ 2021 Job Description Amneal Pharma -Openings for Injectable Manufacturing & Quality Control Sterile Manufacturing (Ophthalmic, PFS and Vial Line) Designation: Executive/ Sr. Officer/ Officer/ Operators Qualification: M. Pharma/ B. Pharma/ Diploma Engineering/ D. Pharma/ B.Sc/ ITI Total Experience: 02 to 07 years …

Amneal Pharmaceuticals Pvt. Ltd- Walk-In Interviews (50 Openings) for Manufacturing / Quality Control On 31st Jan’ 2021 Read More »

NICE recommends new CAR T-cell therapy to treat mantle cell lymphoma

The UK National Institute for Health and Care Excellence (NICE) has recommended a new CAR T-cell therapy to be available to National Health Service (NHS) patients via the Cancer Drugs Fund.  The personalised treatment, called Tecartus or autologous anti-CD19-transduced CD3+, is produced by Kite. NHS clinicians in England will be able to consider the treatment for …

NICE recommends new CAR T-cell therapy to treat mantle cell lymphoma Read More »

Voclosporin approved by FDA to treat lupus nephritis

The Lupus Research Alliance (LRA) has responded to the US Food and Drug Administration’s (FDA) approval of the use of Lupkynis (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis in combination with standard-of-care. Voclosporin has been approved in combination with a background immunosuppressive therapy regimen.  Developed by Aurinia Pharmaceuticals‘, the …

Voclosporin approved by FDA to treat lupus nephritis Read More »

The Other Guys

Writing the other day about the lipid formulations used in the current mRNA vaccines makes me want to highlight something else that I hit on from time to time around here. When you learn in school about the major classes of biomolecules, you hear about proteins, lipids, carbohydrates, and nucleic acids. That’s a reasonable classification, …

The Other Guys Read More »

3 Tips On Managing Seasonality and Improving Cash Flow

Ebbs and flows, seasonal highs, and seasonal lows — every industry has them. Whether your business looks towards summer to shine bright, or towards the winter to capitalize on the holiday spending craze, chances are your business experiences some form of seasonality, or periods of slowdowns.  The ongoing pandemic hasn’t made it any easier: from …

3 Tips On Managing Seasonality and Improving Cash Flow Read More »

Fire at Serum Institute of India, production site of COVID-19 vaccine

According to reports, a fire at the Serum Institute of India (SII) has killed five people. However, government officials have said that this would not affect production of the Oxford-AstraZeneca COVID-19 vaccine that is being made at the facility.  As reported by Reuters, black smoke could be seen coming out of the multi-storey building in …

Fire at Serum Institute of India, production site of COVID-19 vaccine Read More »

President Biden announces intention for US to remain member of WHO

The US has stated that it will remain a member of the World Heath Organization (WHO). US President Joe Biden wrote to António Guterres, Secretary-General of the United Nations (UN), to announce this intention in a letter.  On 6 July 2020, the US notified the UN that it intended to leave the WHO, however the …

President Biden announces intention for US to remain member of WHO Read More »

Health Insurance Battle Royal: Commercial vs. Medicaid

What insurance is better: private commercial health insurance or public health insurance? This is a more difficult question than it seems since individuals with commercial vs. public health insurance differ over a number of dimensions which affect health care spending, quality and outcomes. To try and get at this question, a paper by Allen et …

Health Insurance Battle Royal: Commercial vs. Medicaid Read More »

87% of Americans Want to Receive COVID-19 Vaccine Information From Their Providers

What You Should Know: According to a recent Updox survey, 87% of Americans say they want to receive information from their healthcare provider on COVID-19 vaccine-related news/updates, with their healthcare providers cited as the most trusted source on the topic (34%) — behind health protection agencies (32%), government entities (9%), and the biotechnology companies developing …

87% of Americans Want to Receive COVID-19 Vaccine Information From Their Providers Read More »

Premature Births: Causes, Treatment, Prevention, and Impact of COVID-19

Premature Births: Causes, Treatment, Prevention, and Impact of COVID-19 Premature birth is also known as preterm birth. It is defined as a baby born alive before reaching the gestational age (term to describe the length of pregnancy) of 37 weeks. The typical gestational period is usually 40 weeks which is considered a full-term pregnancy. Premature …

Premature Births: Causes, Treatment, Prevention, and Impact of COVID-19 Read More »

mRNA Vaccines: What Happens

A question that comes up a lot about mRNA vaccines is what happens at the cellular level after you’re injected with one. The mechanism of any such vaccine is to cause cells to produce a viral protein antigen, but which cells actually do this? It’s also understood that mRNA vaccines tend to act as their …

mRNA Vaccines: What Happens Read More »

ONC Names Micky Tripathi New National Coordinator for Health IT

Micky Tripathi, ONC National Coordinator for Health IT – The ONC has named Micky Tripathi as the new National Coordinator for Health IT under President Joe Biden’s administration, succeeding Don Rucker, M.D. who held the post since April 2017. – The Office of the National Coordinator for Health Information Technology is the principal entity charged …

ONC Names Micky Tripathi New National Coordinator for Health IT Read More »

Pfizer COVID-19 vaccine effective against B.1.1.7 variant from UK

Pfizer and BioNTech have announced results from an in vitro study that provides additional data on the capability of sera from individuals immunised with the Pfizer-BioNTech COVID-19 vaccine to neutralise a SARS-CoV-2 UK strain. Also known as B.1.1.7 lineage or VOC 202012/01, the strain is a rapidly spreading variant of SARS-CoV-2 initially detected in the UK …

Pfizer COVID-19 vaccine effective against B.1.1.7 variant from UK Read More »

Clinical microbiology to play key role in COVID-19 response, report says

A new report has said that clinical microbiology will play a key role in understanding SARS-CoV-2 pathogenesis. According to ResearchAndMarkets, as COVID-19 antiviral drugs and vaccine development intensifies, billions of dollars are being invested in over 100 vaccine candidates forcing labs to work at full and extended capacity. The report also says that the global …

Clinical microbiology to play key role in COVID-19 response, report says Read More »

UK vaccine supply chain workers to be offered COVID-19 jabs

Up to 2,000 people working in roles crucial to the continuity of the COVID-19 vaccine supply chain will be offered inoculations against the coronavirus to help ensure the UK gets the doses it needs to protect the most vulnerable, the government has announced. Highly trained workers who have been identified by the government as crucial …

UK vaccine supply chain workers to be offered COVID-19 jabs Read More »

Israel set to be first country to vaccinate entire population against COVID-19

According to a new report, Israel is currently on track to be the first country in the world to vaccinate its entire population against COVID-19. The authors of the report say that this inoculation progress could provide a gold standard for other countries if Israel begins to see no new resurgence in COVID-19 cases in …

Israel set to be first country to vaccinate entire population against COVID-19 Read More »

New system could deliver schizophrenia medicine directly to brain

A team of neuroscientists and engineers has created a nasal spray to deliver schizophrenia medication directly to the brain instead of having it pass through the body. The study was conducted at McMaster University, Canada.  According to the researchers, the leap in efficiency means patients with schizophrenia, bipolar disorder and other conditions could see their …

New system could deliver schizophrenia medicine directly to brain Read More »

Pharma industry employs 5,600 people in Scotland, report says

A new report has revealed the strength of Scotland’s pharmaceutical industry and its value to the economy and communities across the country. Conducted by the University of Strathclyde’s Fraser of Allander Institute, Scotland, the report charts the success of the sector, which has seen an increase in employment, exports and research investment since the last major …

Pharma industry employs 5,600 people in Scotland, report says Read More »

Baricitinib and remdesivir reduce time to recovery in COVID-19 patients

A clinical trial involving hospitalised COVID-19 patients has found that a combination of the drugs baricitinib and remdesivir reduce time to recovery. The study was co-ordinated at the University of Texas Health San Antonio and University Health, US, and was conducted at roughly 100 sites globally. The Adaptive COVID-19 Treatment Trial 2 (ACTT-2), which compared …

Baricitinib and remdesivir reduce time to recovery in COVID-19 patients Read More »

Solving the 50-Year-Old EHR’s Midlife Crisis: How Platform EHRs are Finally Delivering Clinical Intelligence

Over its first 50 years in existence, how did the EHR lose its way? Given that EHR adoption doubled between 2007 and 2012 and EHR expenditures in the United States grew an annual average of 5.4% from 2015 to 2019, totaling $14.5 billion in 2019, this may sound like a strange question to ask. But …

Solving the 50-Year-Old EHR’s Midlife Crisis: How Platform EHRs are Finally Delivering Clinical Intelligence Read More »

Biopharma industry commits to working with regulatory agencies on COVID-19 vaccines

A joint statement from a range of biopharmaceutical industry groups has said they recognise that with the first COVID-19 vaccines authorised by regulatory authorities and administered to the public, a critical new phase of the pandemic has begun. The statement was released by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharmaceutical Research and Manufacturers …

Biopharma industry commits to working with regulatory agencies on COVID-19 vaccines Read More »

Antibiotics market set to generate revenue of $58,800 million by 2027

According to a new report, the global antibiotics market is estimated to generate a revenue of $58,798.1 million at a compound annual growth rate (CAGR) of four percent during the forecast period 2020-2027. The researchers say that the market will increase from its worth in 2019, at $43,298.5 million. The report was compiled by Research Dive. …

Antibiotics market set to generate revenue of $58,800 million by 2027 Read More »

Pfizer COVID-19 vaccine set to generate sales of $30 billion

According to new reports, the COVID-19 vaccine produced by Pfizer and BioNTech, BNT-162b2, is currently projected to generate at least $30 billion in sales from 2020 to 2026. GlobalData, which released the research, said that the vaccine would peak with sales in 2021 worth $13.9 billion.  The report highlights that the Pfizer-BioNTech vaccine, a two-shot …

Pfizer COVID-19 vaccine set to generate sales of $30 billion Read More »

European Commission approves dispersible tablets to treat paediatric HIV

The European Commission (EC) has granted marketing authorisation for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients. ViiV Healthcare, which produces the tablets, said that the therapy is now approved for treatment-naïve or treatment-experienced but …

European Commission approves dispersible tablets to treat paediatric HIV Read More »

Phase III trial to study interferon beta therapy in COVID-19 patients initiated

Synairgen has announced that the first patient has been dosed in the UK a part of a global Phase III trial evaluating the inhaled formulation of interferon beta-1a (SNG001), for the treatment of hospitalised COVID-19 patients.  According to the company, several UK sites have now been initiated, with further sites in the US and EU …

Phase III trial to study interferon beta therapy in COVID-19 patients initiated Read More »

Impact of COVID-19 on quality‐adjusted life‐year lost

We know that COVID-19 has increased both mortality and morbidity around the world. But is there a systematic way of estimating the impact of COVID-19 on both mortality and morbidity. A paper by Briggs et al. (2021) proposes one simple solution. They start by creating standard life tables. Life tables are created by estimating the …

Impact of COVID-19 on quality‐adjusted life‐year lost Read More »

Itamar Medical Acquires Technology and Assets of Spry Health

What You Should Know: – Itamar Medical Ltd. acquired the technology and assets of Spry Health in a move to expand its product offering beyond Sleep Apnea identification. – Itamar Medical’s acquisition of Spry Health will enable the company to develop a wearable watch-like remote patient monitoring solution. Itamar Medical Ltd., a medical device and digital health company focused on …

Itamar Medical Acquires Technology and Assets of Spry Health Read More »

More Things to Do With mRNA

After yesterday’s post on mRNA vaccines and RNA mechanisms, I wanted to highlight a completely non-coronavirus application that has recently appeared in the literature. It’s from BioNTech, the German company who’s been working with Pfizer on one of the two mRNA coronavirus vaccines, of course, but they have other therapeutic interests as well. This latest …

More Things to Do With mRNA Read More »

First patient dosed with COVI-VAC, an intranasal COVID-19 vaccine candidate

The first patient has been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19. The randomised, double-blinded, placebo-controlled dose-escalation study will evaluate the safety and tolerability COVI-VAC at multiple dose levels in a total of 48 volunteers. In addition, the study will …

First patient dosed with COVI-VAC, an intranasal COVID-19 vaccine candidate Read More »

EMA receives authorisation application for AstraZeneca COVID-19 vaccine

The European Medicines Agency (EMA) has announced that it has received an application for conditional marketing authorisation (CMA) for the COVID-19 vaccine developed by AstraZeneca and Oxford University. According to the EMA, the assessment of the vaccine will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January …

EMA receives authorisation application for AstraZeneca COVID-19 vaccine Read More »

Amgen sets target of achieving carbon neutrality by 2027

Amgen has announced the launch of a new seven-year environmental sustainability plan, which includes a commitment to achieve carbon neutrality, while also reducing water use by 40 percent and waste disposed by 75 percent. “As a science-based company with a mission to serve patients, we understand the profound impact that climate change is having on …

Amgen sets target of achieving carbon neutrality by 2027 Read More »

New Year, New You Sweepstakes Official Rules

Quest Presents: New Year New You SWEEPSTAKES Official Rules NO PURCHASE NECESSARY.  A PURCHASE WILL NOT IMPROVE YOUR CHANCE OF WINNING. PROMOTION DESCRIPTION:  The “Quest Presents: New Year New You Giveaway” Sweepstakes (the “Sweepstakes”) begins on or about January 13, 2020 at 12:01 a.m. Pacific Time (“PT”) and ends on […]

RNA Vaccines And Their Lipids

So now that people (not enough of them!) are getting vaccinated in the US with the Pfizer/BioNTech and Moderna mRNA vaccines, let’s talk about some more details of what are in those injections and what happens once the shot is given. The workings of an mRNA vaccine touch on a lot of different cellular processes …

RNA Vaccines And Their Lipids Read More »

FDA monitoring impact of SARS-CoV-2 mutations

The US Food and Drug Administration (FDA) has announced that it is monitoring the potential impact of SARS-CoV-2 viral mutations, including a variant from the UK known as the B.1.1.7 variant. The FDA has alerted clinical laboratory staff and healthcare providers that the agency is using authorised SARS-CoV-2 molecular tests and that false negative results can …

FDA monitoring impact of SARS-CoV-2 mutations Read More »

4 Predictions for Diabetes Management and Technology in 2021

Jordan Messler, MD, SFHM, FACP, Executive Director, Clinical Practice, Glytec The COVID-19 pandemic continues to put an unprecedented amount of strain on the entire healthcare sector, and the industry has responded by accelerating the ways innovation is developed and adopted. Health leaders have faced a generational challenge and the result has been the rapid deployment …

4 Predictions for Diabetes Management and Technology in 2021 Read More »

Rapid microbiology testing market set to be worth over $6 billion in 2026

New research has predicted that the global rapid microbiology testing market will increase to be worth $6.48 billion in 2026, up from $3.45 billion in 2018. According to the report, the market will register a compound annual growth rate (CAGR) of 8.2 percent in the forecast period 2019-2026.  The researchers, from Data Bridge Market Research, …

Rapid microbiology testing market set to be worth over $6 billion in 2026 Read More »

Collaboration to investigate nasal drug delivery using nanoparticle technology

A new collaboration has been established to enhance the nasal drug delivery of Parkinson’s therapies using nanoparticle technology.  Nanoform Finland and Herantis Pharma announced that they have signed a letter of intent to work together on the latter’s CDNF and xCDNF therapies.  The planned and non-exclusive collaboration is intended to assess the utility of Nanoform’s …

Collaboration to investigate nasal drug delivery using nanoparticle technology Read More »

THCB Gang, Episode 37, Jan 7 – LIVE 1pm PT- 4pm ET

Episode 37 of “The THCB Gang” will be live-streamed here 1pm PT / 4pm ET on Thursday, Jan 7. You can see it below! Matthew Holt (@boltyboy) will be joined by regulars: data & privacy expert Deven McGraw, (@Healthprivacy), Patient entrepreneur extraordinaire Robin Farmanfarmaian (@RobinFF3) & consultant/author Rosemarie Day (@Rosemarie_Day1). Balancing them out will be the …

THCB Gang, Episode 37, Jan 7 – LIVE 1pm PT- 4pm ET Read More »

New technique to grow crystals from nanoscale droplets developed

Researchers have grown small crystals from nanoscale encapsulated droplets. According to the scientists, their innovative method, involving the use of inert oils to control evaporative solvent loss, has the potential to enhance the drug development pipeline. The study was conducted at the University of Newcastle and University of Durham, both UK, in collaboration with SPT …

New technique to grow crystals from nanoscale droplets developed Read More »

European Commission approves first treatment for peanut allergy

The European Commission (EC) has approved PALFORZIA® [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy, making it the first treatment for the condition. Produced by Aimmune Therapeutics, a Nestlé Health Science Company, PALFORZIA is indicated in patients aged four to 17 years with a confirmed diagnosis of peanut allergy in conjunction with …

European Commission approves first treatment for peanut allergy Read More »

Microbial surface recovery superior for vinyl than stainless steel

A new study has shown that microbial surface recovery was superior for vinyl when compared with stainless steel, two surfaces common to pharmaceutical facilities.  According to Tim Sandle, the author of the paper, viable environmental monitoring methods in healthcare and pharmaceutical settings remain primarily culture based, with one example being the contact plate. However, although …

Microbial surface recovery superior for vinyl than stainless steel Read More »

Variants and Vaccines

Well, here I am with the first “In the Pipeline” post of 2021, and damn itall, I’m right back to the stuff I was writing about last time. I still expect this year to be the time when we beat back the coronavirus pandemic, and (as a minor side effect for me) to be the …

Variants and Vaccines Read More »

Concerns raised over India’s approval of COVID-19 vaccine with incomplete data

Following India’s approval of the internally developed Covaxin COVID-19 vaccine, experts have raised concerns over whether the jab should have been authorised without sufficient publication of its safety and efficacy data. The vaccine has been given permission to be used “in clinical trial mode… specifically in the context of infection by mutant strains.”  According to …

Concerns raised over India’s approval of COVID-19 vaccine with incomplete data Read More »

USV Pvt. Ltd- Walk-Ins for Multiple Positions On 2nd January 2021

USV Pvt. Ltd- Walk-Ins for Multiple Positions On 2nd January 2021 Job Description Walk-Ins for Multiple Positions -Production / QA / QC / Microbiology / Warehouse / Engineering / Technology Transfer @ USV Pvt. Ltd Walk-In at USV Pvt. Ltd. Daman On 02 January 2021 from 10:00 AM to 03:00 PM, Venue: Plot no 16, 17. Mahatma …

USV Pvt. Ltd- Walk-Ins for Multiple Positions On 2nd January 2021 Read More »

Vaccine Roundup, Late December

There’s been a lot of news, so it’s time to survey the vaccine landscape. For this post, I’m only going to cover the big players that are either deep into human trials or have actually been rolling out vaccines to the general population – another post to come will go further down the list. But …

Vaccine Roundup, Late December Read More »

3 Common Missteps for Manufacturers to Avoid When Securing Medical Devices

Dan Lyon, Sr. Principal Security Consultant at Synopsys Over the last several years of my career, I’ve had the opportunity to work with a variety of global medical device manufacturers.  Recently, I have also started working with some new organizations that are not yet global in scale.  A theme that I have discovered is that …

3 Common Missteps for Manufacturers to Avoid When Securing Medical Devices Read More »

Optimised formulation of gentamicin could reduce hearing loss

A novel method of purifying gentamicin, a widely used antibiotic, reduces the risk that it will cause deafness, according to new study. The new formulation to prevent hearing loss was developed at Stanford Medicine, US.  Gentamicin is used in US hospitals to treat a variety of bacterial infections. It is a popular drug in developing …

Optimised formulation of gentamicin could reduce hearing loss Read More »

How did we get the COVID-19 vaccine so fast?

In short, because we had built years and years of previous science, particularly work related to another corona virus, the Middle East Respiratory Syndrome (MERS) virus. As This American Life reports on the speed of vaccine development: That’s because the spike on this coronavirus that would cause the pandemic, it was very, very similar to …

How did we get the COVID-19 vaccine so fast? Read More »

Holiday Break

I’ll be taking a holiday break, with intermittent blogging. I hope to put in a recipe or two (as often happens around here this time of year), and I’ll certainly pop up if we have some big news. Otherwise, from now until January 2nd I’ll be on my end-of-the-year schedule. 2020 has been. . .well, …

Holiday Break Read More »

The New Mutations

OK, time to write about the topic that’s been the talk of the coronavirus world the last day or two: the new strain that has been detected in the UK. I’ll go ahead and put the bottom line right here, and then go into the details: I’m not sounding any alarm bells, but this does …

The New Mutations Read More »

EC orders additional 80 million doses of Moderna’s COVID-19 vaccine

Moderna has announced that the European Commission (EC) has exercised its option to purchase an additional 80 million doses of mRNA-1273, the company’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 160 million doses. The first deliveries of mRNA-1273 to European countries from Modena’s dedicated European supply chain are expected to commence early in …

EC orders additional 80 million doses of Moderna’s COVID-19 vaccine Read More »

Antibody-Dependent Enhancement

I’ve had several questions about antibody-dependent enhancement, which has always been a worry as the coronavirus vaccines have been developed. I figured it might be worth a look at just what we know about it, why one might be worried, and why (on the other hand) one might be hopeful. The simple definition of ADE …

Antibody-Dependent Enhancement Read More »

Autoantibody Problems

Here’s a preprint from a large team at Yale with a close look at a less-studied aspect of coronavirus infection. It’s been well established by now that a feature of severe cases is a misfiring immune response (the “cytokine storm”, etc.), and one reason that fatality rates have been going down for hospitalized cases is …

Autoantibody Problems Read More »

Baricitinib Follow-Up: An AI Prediction for Coronavirus Therapy

I wanted to follow up on something that came up much earlier in the coronavirus pandemic. Back in February, a group at BenevolentAI proposed the kinase inhibitor baricitinib as a possible therapeutic for the coronavirus. They identified this through their company’s machine-learning approach to the medical literature and disease mechanisms, and identified the compound due …

Baricitinib Follow-Up: An AI Prediction for Coronavirus Therapy Read More »

Gene Therapy, Absolutely and For Real

This weekend brought some really significant news in the long-running effort to use gene editing to treat human disease. As most readers will have heard, Bluebird and a Vertex/CRISPR effort both published papers in the NEJM addressing sickle-cell anemia and beta-thalassemia. These diseases have long been linked when it comes to gene therapy ideas, because …

Gene Therapy, Absolutely and For Real Read More »

Get Ready for False Side Effects

We’re in the beginning of the vaccine endgame now: regulatory approval and actual distribution/rollout into the population. The data for the Pfizer/BioNTech and Moderna vaccines continue to look good (here’s a new report on the longevity of immune response after the Moderna one), with the J&J and Novavax efforts still to report. The AZ/Oxford candidate …

Get Ready for False Side Effects Read More »

Insights+ Key Biosimilars Events of November 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of November 2020 Read More »

What is the impact of FDA review time on pharmaceutical R&D investments?

This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK recently has approved the Pfizer/BioNTech vaccine for COVID-19 before the US. Unlike most studies that attempt to examine the relationship between FDA review time and R&D investment dollars, the authors …

What is the impact of FDA review time on pharmaceutical R&D investments? Read More »

Protein Folding, 2020

Every two years there’s a big challenge competition in predicting protein folding. That is. . .well, a hard problem. Protein chains have (in theory) an incomprehensibly large number of possible folded states, but many actual proteins just manage to arrange themselves properly either alone or with a few judicious bumps from chaperones. It’s been clear …

Protein Folding, 2020 Read More »

Philips Unveils Vendor-Neutral Radiology Operations Command Center, Automated Radiology Workflow Suite

What You Should Know: – Philips unveils a new multimodality virtual imaging command center that enables real-time, remote collaboration to broaden expertise between technologists, radiologists, and imaging operations teams across multiple sites via private, secure telepresence capabilities. – In addition, Philips debuts AI-enabled, automated Radiology Workflow Suite at RSNA 2020 to advance precision diagnosis into clear …

Philips Unveils Vendor-Neutral Radiology Operations Command Center, Automated Radiology Workflow Suite Read More »

Oxford/AZ Vaccine Efficacy Data

As of this morning, we have a first look at the Oxford/AstraZeneca vaccine’s efficacy in clinical trials via press releases from both organizations. The number in the headlines says about 70% efficacy, but there’s more to the story. Here’s the landscape so far: we have results from Pfizer and from Moderna, both of them developing …

Oxford/AZ Vaccine Efficacy Data Read More »

How much extra COVID-19 risk would you be willing to accept to open the economy?

That is the basic question that Reed et al. (2020) attempt to answer in their recent paper. The approach they use is as follows: We designed a discrete-choice experiment to administer 10 choice questions to each respondent representing experimentally controlled pairs of scenarios defined by when nonessential businesses could reopen (May, July, or October 2020), …

How much extra COVID-19 risk would you be willing to accept to open the economy? Read More »

Vaccine Possibilities

Now that we’re seeing that coronavirus vaccines are indeed possible (and are on their way), let’s talk about the remaining unanswered questions and the things that we will be getting more data on. Here are some of the big issues – it’ll be good to see this stuff coming into focus. I’ll put these into …

Vaccine Possibilities Read More »

AliveCor Lands $65M to Advance Remote Cardiology Platform Worldwide

What You Should Know: Today AliveCor, the leader in AI-based, personal ECG devices and cardiology platforms, announced they closed $65 million in Series E funding to accelerate its growth. To date, AliveCor’s FDA-cleared Kardia devices have recorded more than 85 million ECGs. Since the pandemic began, nearly 15 million ECGs were taken which is an …

AliveCor Lands $65M to Advance Remote Cardiology Platform Worldwide Read More »

Medtronic Launches Smart Insulin Pen Integrated with Real-Time CGM Data

What You Should Know: – Medtronic, the global leader in medical technology, announced the launch of InPen integrated with real-time Guardian Connect Continuous Glucose Monitoring (CGM) data. – InPen is the first and only FDA-cleared smart insulin pen on the market for people on multiple daily injections (MDI). – The combined solution now provides real-time …

Medtronic Launches Smart Insulin Pen Integrated with Real-Time CGM Data Read More »

THCB Gang Episode 32 LIVE 1PM PT/4PM ET

Episode 32 of “The THCB Gang” will be live-streamed on Thursday, November 12th. Tune in below! Matthew Holt (@boltyboy) will be joined by some of our regulars: WTF Health Host Jessica DaMassa (@jessdamassa), radiologist Saurabh Jha (@RougeRad), MD-turned entrepreneur Jean-Luc Neptune (@jeanlucneptune), communications leader Jennifer Benz (@jenbenz), THCB’s Editor-in-Chief me (zoykskhan) and guest Jeff Goldsmith, …

THCB Gang Episode 32 LIVE 1PM PT/4PM ET Read More »

HST Pathways and Casetabs Merge to Form ASC Practice Management Powerhouse

What You Should Know: – HST Pathways and Casetabs announce merger to power surgical communication combined with the industry leader in ASC practice management. –  The combined company is supported by a majority investment led by private equity company Bain Capital Tech Opportunities with a minority investment from Nexxus Holdings. HST Pathways (“HST”) and Casetabs, two leading providers …

HST Pathways and Casetabs Merge to Form ASC Practice Management Powerhouse Read More »

Innovaccer, Surescripts Integrate to Leverage Medication Data for Patients

What You Should Know: – Innovaccer partners with Surescripts to power its data activation platform with the most comprehensive medication data. – The partnership will enable the company to conduct smart medication reconciliation and ensure that patients are complying with their care protocols. Innovaccer, Inc., a San Francisco, CA-based healthcare technology company, announced its partnership …

Innovaccer, Surescripts Integrate to Leverage Medication Data for Patients Read More »

How Yale-New Haven Uses IPA in Revenue Cycle to Tackle Inefficiency

As the pandemic heads toward a second year with no further financial stimulus guaranteed, hospitals and health systems are seeking ways to reduce costs and improve revenue cycle performance. Intelligent process automation (IPA) is an emerging solution designed to optimize operations and increase productivity through a combination of process modeling, process automation, and artificial intelligence.  …

How Yale-New Haven Uses IPA in Revenue Cycle to Tackle Inefficiency Read More »

Vaccine Efficacy Data!

Earlier this morning, Pfizer and BioNTech announced the first controlled efficacy data for a coronavirus vaccine. And the news is good. You may recall that these vaccine trials are set up to get to a defined number of coronavirus cases overall, at which time the various monitoring committees lock the door and unblind the data …

Vaccine Efficacy Data! Read More »

Aducanumab at the FDA

So it’s finally time for Biogen to sit down with an FDA advisory committee to look at their proposed Alzheimer’s therapy, the anti-amyloid antibody aducanumab. I last wrote about it here, back in December, and you know what? I haven’t changed my mind a bit, because (1) no new data have emerged (none were expected) …

Aducanumab at the FDA Read More »

Shodhana Laboratories-Walk-In Interviews for Freshers On 4th Nov’ to 7th Nov’ 2020

Shodhana Laboratories-Walk-In Interviews for Freshers On 4th Oct’ to 7th Nov’ 2020 Walk-In Interviews for B.Pharm/ M.Pharm/ M.Sc/ Any Degree Freshers @ Shodhana Laboratories Limited Job Description We are happy to provide an Opportunity for Freshers Qualification: Any Degree, B.Pharmacy, M.Pharmacy, M.Sc, Any Other Graduation. (Only For Male Candidates).Contact: 7659095552(What’s app ). If You’re Interested in Production only …

Shodhana Laboratories-Walk-In Interviews for Freshers On 4th Nov’ to 7th Nov’ 2020 Read More »

The Scientific Literature’s Own Pandemic

One side effect of the coronavirus has been an explosion of lower-quality publications in the scientific literature. This has come in several forms, some more excusable than others. In the former category are the papers that were rushed out earlier this year, observational studies that sometimes investigated possible therapies as well. These were often done …

The Scientific Literature’s Own Pandemic Read More »

Longevity

Wouldn’t be great if we could find a treatment to improve longevity? Not just a treatment for a specific disease but one that could dramatically improve longevity for a large percentage of human kind. While there is a lot of longevity research going on and much progress has been made. There are some challenges. Milan …

Longevity Read More »

Down to the Atoms

I wanted to mention something that was reported a week or so ago, and may sound a bit exotic or obscure, if you’re not a structural biologist. But it’s yet another sign of a revolution in our ability to get structures of biomolecules (and others) that we never would have before, and the effects over …

Down to the Atoms Read More »

The Latest Antibody Data From Lilly and From Regeneron

We have a new paper in the NEJM from the Eli Lilly effort on monoclonal antibodies against the coronavirus. And there’s no reason not to be up front about it: it’s disappointing. This is the BLAZE-1 trial (mentioned in this recent post), which is studying non-hospitalized patients. It was another trial (ACTIV-3) where this antibody …

The Latest Antibody Data From Lilly and From Regeneron Read More »

Rehash: The Health Assurance SPAC

Not so long ago (August) Jessica DaMassa and I ran a THCB Bookclub interview with Hemant Teneja & Stephen Klasko about their new book UnHealthcare. And, just because, their friend Glen Tullman sat in….. Fast forward to this week and the three of them plus a cast of characters from General Catalyst & Livongo (Jenny …

Rehash: The Health Assurance SPAC Read More »

Click Chemotherapy

So here’s an ambitious idea that’s about to get a hearing in human clinical trials. A startup called Shasqi is using click chemistry as a drug delivery method, and they have a new manuscript on the idea here at ChemRxiv. The idea is this: you produce a modified version of a hyaluronate biopolymer, decorated with …

Click Chemotherapy Read More »

Will California Produce and Distribute Biosimilars and Generics Drugs?

As AJMC reports, Governor Gavin Newsom signed into law legislation that will allow California to produce and distribute its own line of biosimilars, biosimilar insulins, and generic drugs. My thoughts on SB-852 are covered in an interview in Radar on Specialty Pharmacy. Shafrin tells AIS Health that there are two key reasons for manufacturers to …

Will California Produce and Distribute Biosimilars and Generics Drugs? Read More »

More Antibody Data

Unfortunately, we’re getting a dose these days of “That’s why you run clinical trials”. Word came Monday evening (Peter Loftus in the WSJ, and a Lilly statement) that the ACTIV-3 trial being run by the NIH has shown lack of efficacy for the combination of the Eli Lilly/AbCellera anti-coronavirus antibody (bamlanivimab, LY-CoV555) when combined with …

More Antibody Data Read More »

Medtronic’s Abre Venous Stent Receives the US FDA’s Approval to Treat Venous Outflow Obstruction

Shots: The approval is based on ABRE clinical study assessing the Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with the post-thrombotic syndrome, NIVL & those who presented with an aDVT. The study also includes a challenging patient population, 44% of whom required stents …

Medtronic’s Abre Venous Stent Receives the US FDA’s Approval to Treat Venous Outflow Obstruction Read More »

The Vaccine Tightrope

We’re getting closer to having to deal with a number of tricky issues around the first Emergency Use Authorizations (EUAs) for coronavirus vaccines. These have never quite come up in this way before, because (for one thing) EUAs for vaccines are relatively rare events, and (for another) we’ve never had so many simultaneous vaccine trials …

The Vaccine Tightrope Read More »

The Machines Rise a Bit More

Here’s a new paper in Nature on computer-generated synthesis of natural products. More formally, you’d call it retrosynthesis, since the htought process in organic chemistry tends to work backwards when you have a particular target that you’re trying to make: “OK, this part could could be made from something like this. . .and that, you …

The Machines Rise a Bit More Read More »

The SOLIDARITY Data

OK, we have some more to think about this morning. The large SOLIDARITY trial from the WHO has reported more interim data on its investigation into repurposed drugs for the coronavirus pandemic. And some of this we already knew, but some of it’s a real surprise. One drug reported on is hydroxychloroquine. This showed no …

The SOLIDARITY Data Read More »

Immunity and Re-Infection

For months now, people have been watching closely to see if it’s possible to get re-infected with the coronavirus. It’s taken a while for the signal-to-noise to get better, but by now there’s no doubt that the answer is yes, it’s possible. We’ve just had the first of these in the US, a man in …

Immunity and Re-Infection Read More »

Another Vaccine Trial Halt

The first advice is “Don’t panic”. You will have heard that last night J&J announced that their coronavirus vaccine dosing has been paused while they investigate an adverse event in the trial. And while you never like to hear that, considering the size of their effort, this sort of thing is likely to happen even …

Another Vaccine Trial Halt Read More »

2020 Economics Nobel Prize: Paul Milgrom and Robert Wilson

Congratulations to Paul Milgrom and Robert Wilson for the 2020 Nobel Prize in Economics. Below is an excerpt from the press release. Using auction theory, researchers try to understand the outcomes of different rules for bidding and final prices, the auction format. The analysis is difficult, because bidders behave strategically, based on the available information. They …

2020 Economics Nobel Prize: Paul Milgrom and Robert Wilson Read More »

2020 Economics Nobel Prize: Paul Milgrom and Robert Wilson

Congratulations to Paul Milgrom and Robert Wilson for the 2020 Nobel Prize in Economics. Below is an excerpt from the press release. Using auction theory, researchers try to understand the outcomes of different rules for bidding and final prices, the auction format. The analysis is difficult, because bidders behave strategically, based on the available information. They …

2020 Economics Nobel Prize: Paul Milgrom and Robert Wilson Read More »

Target Locations: Meat Lover’s Pizza

**Target locations listed in alphabetical order by State** We highly suggest you check Target.com or call any store ahead of time to guarantee availability. address city state zip 6275 University Dr NW Huntsville AL 35806-1776 2750 Carl T Jones Dr SE Huntsville AL 35802-4914 790 Schillinger Rd S Mobile AL 36695-8979 4616 […]

Target Locations: Quest Chocolate Chip Protein Cookie – 8 Pack

**Target locations listed in alphabetical order by State** We highly suggest you check Target.com or call any store ahead of time to guarantee availability. Address City State Zip 1801 E Parks Hwy Wasilla AK 99654-7350 1200 N Muldoon Rd Anchorage AK 99504-6103 3150 Bel Air Mall Mobile AL 36606-3203 1698 […]

CRISPR inventors win Nobel Prize in Chemistry

From the Nobel Prize website: Emmanuelle Charpentier and Jennifer A. Doudna have discovered one of gene technology’s sharpest tools: the CRISPR/Cas9 genetic scissors. Using these, researchers can change the DNA of animals, plants and microorganisms with extremely high precision. This technology has had a revolutionary impact on the life sciences, is contributing to new cancer …

CRISPR inventors win Nobel Prize in Chemistry Read More »

Cigna’s Evernorth Expands Digital Health Formulary with Addition of Omada MSK by Physera

What You Should Know: – Cigna Corporation’s health services segment, Evernorth expands its digital health formulary with the addition of Omada MSK by Physera. – Omada MSK by Physera joins Omada’s existing formulary programs for diabetes prevention, type 2 diabetes, and hypertension. Cigna Corporation’s health services segment Evernorth today announced the expansion of its industry-first …

Cigna’s Evernorth Expands Digital Health Formulary with Addition of Omada MSK by Physera Read More »

A Nobel for CRISPR

The 2020 Chemistry Nobel has gone to Jennifer Doudna and Emmanuelle Charpentier for the discovery of CRISPR. An award in this area has been expected for some time – it’s obviously worthy – so the main thing people have been waiting for is to see when it would happen and who would be on it. …

A Nobel for CRISPR Read More »

Q3 2020 Digital Health Funding Breaks $4B: 3 Key Trends to Know

What You Should Know: – Digital health funding reached a record-breaking $4.0B in Q3 2020 for a total of $9.4B year to date, according to the latest Rock Health quarterly report. – Twenty-four (24) digital health companies have raised mega deals of $100M or more through Q3 of 2020. The rise in mega deals reflects …

Q3 2020 Digital Health Funding Breaks $4B: 3 Key Trends to Know Read More »

Quest and 300 4k Movie Sweepstakes

Quest and 300 4k Movie Sweepstakes Official Rules NO PURCHASE NECESSARY.  A PURCHASE WILL NOT IMPROVE YOUR CHANCE OF WINNING. PROMOTION DESCRIPTION:  The “Quest and 300 4k Movie” Sweepstakes (the “Sweepstakes”) begins on or about October 6, 2020 at 12:01 a.m. Pacific Time (“PT”) and ends on October 12, 2020 […]

Should more flexible health care professional licensing continue after COVID-19?

Shirley Svorny and Michael Cannon of the Cato Institute have a long history (see here) of criticizing government licensing of physicians and other health care providers (e.g., nurse practitioners [NPs], nurses). Their proposed alternative has been to allow private entities to certify the competence of practitioners. They claim that private entities would increase competition by …

Should more flexible health care professional licensing continue after COVID-19? Read More »

BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

Shots: Forbius will receive up front and milestones while BMS will acquire Forbius’s TGF-beta program, including the lead investigational asset, AVID200. The transaction is expected to be closed in Q4’20 Prior to closing, Forbius’ non-TGF-beta assets will be transferred to a newly formed private company, which will be retained by Forbius’ existing shareholders AVID200 is …

BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis Read More »

Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older

Shots: The EC has granted MAA to Kaftrio (ivacaftor/tezacaftor/lumacaftor) + ivacaftor (150mg) to treat people with CF aged ≥12yrs. with one F508del mutation and one minimal function mutation (F/MF), or two F508del mutations (F/F) in the CFTR gene The MAA is based on two P-III studies i.e. a 24wks. study in 403 people with one …

Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older Read More »

Sole-Source, Off-Patent Drugs: Are prices rising out of control?

In the news, we often hear of pharma companies dramatically raising the price of off-patent but sole-sourced drugs. For instance, Martin Shkreli–formerly of Turing pharmaceuticals–raised the price of Daraprim, an antiparasitic drug, from $13.50 to $750 per pill. Is this a common occurrence or is the news media blowing it out of proportion? A recent …

Sole-Source, Off-Patent Drugs: Are prices rising out of control? Read More »

The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R Multiple Myeloma

Shots: The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd)  in two dosing regimen (70 mg/m2 , qw and 56 mg/m2 , q2w) for the treatment of adult patients with r/r MM who have received 1-3L therapies The approval of q2w dosing regimen is based on P-III CANDOR study assessing …

The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R Multiple Myeloma Read More »

Drug Repurposing: An Overview 

This article was originally published by Mahendra Saini, Nikhita Parihar, Shankar Lal Soni, and Vandana Sharma in the Asian Journal of Pharmaceutical Research and Development. 2020; 8(4): 194-212 under an… The post Drug Repurposing: An Overview  appeared first on DrugPatentWatch – Make Better Decisions.

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Shots: The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further Regeneron will lead the distribution in the US while Roche will be responsible for the …

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19 Read More »

Links

Kamala Harris on health. COVID data quality. African-American views on US health policy. Impact of treatment advances on lung cancer mortality. Trends in deaths of despair.

Pharma Whatsapp Group

Pharma Whatsapp Group Whatsapp When Join Pharma Pathway Group You get 250+ vacancies direct Your Phone Group Rules – Welcome to Everyone Pharma Pathway Some Rules To Be Followed In This Group: 1. People will be removed from the group without any intimation, if u sends irrelevant posts such as Good morning, Good Night, Forwarded …

Pharma Whatsapp Group Read More »

Nanobodies Against the Coronavirus: Something New

So let’s talk about nanobodies – there’s a coronavirus connection to this, but it’s a good topic in general for several reasons. We begin at the beginning: what the heck is a “nanobody”? Antibody Structure The name is derived, rather loosely, from “antibody”. So let’s spend a minute on what antibodies actually look like. What …

Nanobodies Against the Coronavirus: Something New Read More »

Automating Safety Case Processing: The Options

Register now The promise of EMR/HER data is receiving increased attention as clinical researchers and patients continue a decade’s long mission to more effectively and rapidly enroll patients on clinical trials; bring new treatment options to market; and improve clinical trial cycle time. Despite vast quantities of available data, its dispersion among dissimilar systems and …

Automating Safety Case Processing: The Options Read More »

That Kodak Deal

Many people have been wondering what’s going on with the announcement by the Trump administration that Kodak has been contracted to produce pharmaceutical APIs here in the US. Let’s line up some of the public statements about all this first, and then take a closer look. Here’s the press release from Kodak after signing a “Letter …

That Kodak Deal Read More »

Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease

Shots: Oxford Biomedica will manufacture GMP batches for Axovant to support the ongoing and future clinical development of AXO-Lenti-PD (formerly OXB-102) to treat mod. to sev. PD based on Oxford’s LentiVector platform Axovant is conducting a P-II SUNRISE-PD trial with AXO-Lenti-PD while the dosing of all patients in the second cohort is completed with 6mos. …

Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease Read More »

Complete Guide on Buying Medicines from Online Pharmacies

Thanks to online pharmacies, the ability to treat complex health issues is strengthened as one can avail advanced medicines from any corner of the world. The power of the internet is in full strength that doorstep delivery of medicines is possible. Buying online drugs safely is still a major concern because after all, medicines must …

Complete Guide on Buying Medicines from Online Pharmacies Read More »

Umedica Laboratories -Walk-In Interviews for Freshers & Experienced On 27th to 29th July’ 2020

Umedica Laboratories -Walk-In Interviews for Freshers & Experienced On 27th to 29th July’ 2020 Umedica Laboratories -Walk-In Interviews for Freshers & Experienced -Manufacturing / Packing / Injection / QA Departments Time & Venue Details : Walk-In On 27th to 29th July’ 2020 At Umedica Laboratories, Plot No 221, II Phase GIDC Nr Morarji Circle Vapi. …

Umedica Laboratories -Walk-In Interviews for Freshers & Experienced On 27th to 29th July’ 2020 Read More »