Month: October 2020
Catalent continues big push into cell and gene therapies with Belgian facility buyout
Catalent continues big push into cell and gene therapies with Belgian facility buyout kblankenship Thu, 10/29/2020 – 10:57
Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book – 10/27/2020 – 10/28/2020
Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book
Nucleus accumbens recruited by cocaine, sugar are different
In a study using genetically modified mice, researchers found that the nucleus accumbens recruited by cocaine use are largely distinct from nucleus accumbens recruited by […]
Providing Regulatory Submissions in Electronic Format — Standardized Study Data
Electronic Submissions
Health systems join forces with shared laundry facility in Detroit
With COVID-19 cases on the rise in Michigan and flu season approaching, healthcare executives said in a news conference that demand for clean laundry has become […]
FBI warns ransomware assault threatens healthcare system
Federal agencies warned that cybercriminals are unleashing a wave of data-scrambling extortion attempts against the U.S. healthcare system designed to lock up hospital information systems, […]
Documents show ‘political’ nature of Trump COVID ad campaign, lawmakers say
A Trump administration official suggested that the theme of a roughly $250 million taxpayer-funded ad campaign to “defeat despair” around coronavirus could be “Helping the […]
Neuland Laboratories Limited-Walk-In Interviews for Freshers & Experienced On 31st Oct’ 2020
Neuland Laboratories Limited-Walk-In Interviews for Freshers & Experienced On 31st Oct’ 2020 Department: Production-APIQualification: B.Sc / Diploma Venue: Pharma Patashala, Miyapur, Hyderabad For any Queries please Contact at […]
Hospital bills for uninsured COVID patients are covered, but no one tells them
Among clinicians, there’s a reluctance to raise the issue of cost in any way and run afoul of federal laws. Emergency rooms must at least […]
Teladoc ups guidance for third quarter in a row as telehealth use holds steady
Jefferies analyst David Windley called the results “robust overall but mixed in the details,” calling membership growth underwhelming, and shares fell.
Integration of Movilitas.Cloud and NiceLabel simplifies serialised label printing for highly regulated industries
Movilitas has announced the integration of its Movilitas.Cloud with NiceLabel’s cloud-based label printing solution to simplify serialised label printing for highly regulated industries. With 50 […]
CMS requires government, most private plans to cover COVID-19 vaccines
Commercial payers are likely already modeling costs. Anthem CEO Gail Boudreaux said Wednesday the insurer considered multiple variables when determining pricing and will follow CMS guidance.
Gilead’s Covid-19 Drug Is Mediocre. It Will Be a Blockbuster Anyway.
Gilead Sciences said Wednesday that remdesivir, which has been authorized for emergency use since the spring, brought in $873 million in revenues so far this […]
Gilead’s Covid-19 Drug Is Mediocre. It Will Be a Blockbuster Anyway.
Gilead Sciences said Wednesday that remdesivir, which has been authorized for emergency use since the spring, brought in $873 million in revenues so far this […]
Gilead’s Covid-19 Drug is Mediocre. It Will Be a Blockbuster Anyway.
Gilead Sciences said Wednesday that remdesivir, which has been authorized for emergency use since the spring, brought in $873 million in revenues so far this […]
PharmaShots’ Key Highlights of Third Quarter 2020
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, […]
Watch out Merck: FDA grants Regeneron, Sanofi’s Libtayo priority review for coveted first-line use in lung cancer
Watch out Merck: FDA grants Regeneron, Sanofi’s Libtayo priority review for coveted first-line use in lung cancer arlene.weintraub Thu, 10/29/2020 – 09:58
New Trump policy will force insurers to disclose prices up front
Health insurers will be required to publicly post, in advance, the price for the most common services and procedures, under a rule finalized by the […]
WuXi STA: increasing demand fueling ‘robust’ HPAPI market
A leader from the STA Pharmaceutical subsidiary of WuXI AppTec talks about the dynamic HPAPI market and whatâs ahead for their operation.
#NoGoingBack mission brings trial pros together
A new movement is working to bring leaders together from all corners of clinical research for to work toward the continued success of the industry.
Deep Learning Tool May Accelerate COVID-19 Drug Discovery
A deep learning tool can… read more
CMS finalizes insurer transparency rule
The rule forces employer health plans and insurance companies to post in-network and out-of-network rates they negotiate with providers. It also requires insurers to develop […]
Takeda, Moderna partner up to bring 50M coronavirus shots to Japan
Takeda, Moderna partner up to bring 50M coronavirus shots to Japan kblankenship Thu, 10/29/2020 – 09:06
Fitbit, Northwell Health test wearables’ ability to detect Covid-19 early
After sharing early data from a study of its wearables’ ability to detect Covid-19 early, Fitbit plans to launch a prospective study with Northwell Health […]
November 2, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement – 11/02/2020 – 11/02/2020
November 2, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Fauci: Maybe 2022 before US sees ‘some semblances of normality’
Top infectious disease expert Anthony Fauci said Wednesday that it might be 2022 until the U.S. sees “some semblances of normality.”During a University of Melbourne […]
Govt revises PLI scheme guidelines to boost local production of bulk drugs, medical devices
Post issuance of the detailed guidelines, the department received several suggestions and inputs from the pharmaceutical and medical device industry seeking certain amendments in the […]
Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19
Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will […]
What White Blood Cell Count Should We Shoot for?
At the start of my video What Does a Low White Blood Cell Count Mean?, you can see what it looks like when you take […]
NHS England praises GPs after steep rise in general practice appointments
NHS England primary care medical director Dr Nikki Kanani has thanked GPs and their teams after official data showed general practice delivered 26.65m appointments last […]
NHS England praises GPs after steep rise in appointments in general practice
NHS England primary care medical director Dr Nikki Kanani has thanked GPs and their teams after official data showed general practice delivered 26.65m appointments last […]
CStone Signs a License Agreement with LegoChem for LCB71 to Treat Multiple Cancer Indications
Shots: LCB to receive $10 M as upfront, and up to $353.5M as cumulative milestone payments along with royalties on sales of LCB71. CStone get […]
Fauci expresses support for national mask mandate
The nation’s top infectious disease expert, Dr. Anthony Fauci, expressed support for a national mask mandate in an interview late Wednesday with CNBC.Fauci explained that […]
Novartis keeps a close eye on gene therapy with Vedere Bio buy
Already a major player in gene therapy, Novartis has swooped on US startup Vedere Bio in a $280 million deal that builds its position in […]
Gilead Q3 revenue rise bolstered by $873m Veklury sales
Gilead Sciences is the first and so far only company to claim FDA approval for a COVID-19 treatment with its Veklury antiviral, and its latest […]
BMS joins forces with insitro to develop neurodegenerative treatments
insitro has landed another big biopharma partnership, signing a five-year collaboration with Bristol Myers Sqibb to develop therapies for amyotrophic lateral sclerosis (ALS) and frontotemporal […]
NICE talking to you: Trends in early HTA engagement
With exclusive data from Freedom of Information (FOI) requests sent to the National Institute for Health and are Excellence (NICE), Leela Barham takes a look […]
Guidances (Drugs)
Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA’s […]
Novartis Acquires Vedere Bio for $280M
Shots: Vedere Bio received $150M as upfront payments and is eligible to receive up to $130M as milestones making a total deal value of $280M. […]
Healthcare providers’ campaign spending skews toward Democrats
A greater share of hospitals’ and nursing homes’ political contributions have gone to Democrats in 2020 than in prior election cycles.
Micro Labs Limited-Walk-In Interviews for Quality Control Department On 31st Oct’ & 7th Nov’ 2020
Micro Labs Limited-Walk-In Interviews for Quality Control Department On 31st Oct’ & 7th Nov’ 2020 Micro Labs Limited-Walk-In Interviews for Quality Control Department On 31st […]
Sen. Graham Complains That 3 Blue States Get a Third of ACA Funding
Sen. Lindsey Graham has never been a fan of the Affordable Care Act — even though it’s helped dramatically lower the number of uninsured people […]
Hospital Bills for Uninsured COVID Patients Are Covered, but No One Tells Them
When Darius Settles died from COVID-19 on the Fourth of July, his family and the city of Nashville, Tennessee, were shocked. Even the mayor noted […]
Despite COVID Concerns, Teams Venture Into Nursing Homes to Get Out the Vote
RALEIGH, N.C. — Each time Beverly Tucker visited a nursing home or long-term care facility this fall, she brought along a rolling tote bag packed […]
App-Based Companies Pushing Prop. 22 Say Drivers Will Get Health Benefits. Will They?
App-based driving services such as Uber, Lyft, DoorDash and Instacart are bankrolling California’s Proposition 22, which would keep their drivers classified as independent contractors, not […]
The Stressful Conclusion of a Clinical Trial
Does a pharmaceutical company have a moral obligation to acknowledge my participation with an ongoing supply of the product that I helped test?
The Stressful Conclusion of a Clinical Trial
Does a pharmaceutical company have a moral obligation to acknowledge my participation with an ongoing supply of the product that I helped test?
The Trump Medicaid Record: Big Goals, Yet Few Successes
President Donald Trump entered office seeking a massive overhaul of the Medicaid program, which had just experienced the biggest growth spurt in its 50-year history. […]
Why Many White Men Love Trump’s Coronavirus Response
The far-right group Super Happy Fun America protests in Boston on October 18. (Mark Peterson / Redux) Kurtis, a young accountant in McKinney, Texas, likes […]
Donald Trump, Coronavirus Hero
The far-right group Super Happy Fun America protests in Boston on October 18. (Mark Peterson / Redux) Kurtis, a young accountant in McKinney, Texas, likes […]
Dr Reddy’s partners with Department of Biotechnology for Sputnik V vaccine clinical trials in India
Chairman of Dr Reddys Laboratories, Satish Reddy said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the […]
Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine
Shots: The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms […]
SC seeks Centre’s reply on plea alleging no approval for Remdesivir, Favipiravir to treat COVID-19
Advocate M L Sharma petitioner in-person referred to the bench, also comprising Justices A S Bopanna and V Ramasubramanian, the World Health Organization (WHO) report […]
Novartis sets sights on potential COVID-19 antivirals from Molecular Partners
Collaboration includes two therapeutic candidates – MP0420 and MP0423
Sanofi teams up with MSD to test new oncology treatment
French pharma will test investigational candidate alongside MSD’s Keytruda
NICE recommends testing womb cancer patients for inherited condition
New guidance based on research from University of Manchester
BMS collaborates with insitro to develop drugs for ALS
Agreement will also see companies develop treatments for frontotemporal dementia
Zydus Cadila gets tentative nod from USFDA to market diabetes drug
The company said the newly approved medication will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting
Shots: The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting […]
THCB “SPOOKY” Gang: Episode 30 10/29 LIVE 1PM/4PM ET
Episode 30 of “The THCB Gang” was live-streamed on Thursday, October 28th! Tune in below! Matthew Holt (@boltyboy) will be joined by some of our […]
BMS Signs a Five-Year Agreement with Insitro to Develop Therapies for ALS and Frontotemporal Dementia
Shots: Insitro to receive $50M as up front, $20M as near-term operational milestones and is eligible to receive ~$2B+ as discovery, development, regulatory and commercial […]