Sat.May 01, 2021 - Fri.May 07, 2021

Two biotechs team up to bring CRISPR to 'natural killer' cell therapy

Bio Pharma Dive

A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy

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Pfizer wants it all

World of DTC Marketing

QUICK THOUGHT: Pfizer has already made $24 billion from their COVID vaccine, but that’s not enough; they want more, a lot more. They are planning to increase the vaccine price, and they’re working on an oral pill that could bring in as much as an additional $2 billion. While the U.S.

FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers.

From Insurance Claim Denials to Smiles, Payment and Feeling Empowered

Triage Cancer

Have you ever received a denial from your insurance company? Me too. Just days before my scheduled breast reconstruction surgery. You probably know how I felt. Blindsided. Frustrated. Angry. . I won't make you read this whole article to learn that I appealed that denial and won.

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Pharma erupts as Biden administration backs waiver of vaccine patent rights

Bio Pharma Dive

The shift in U.S. policy might not undermine future research as the drug industry claims. Easing patent protections, though, isn't likely to translate to an immediate boost in vaccine supply

Drugs 197

Corporations: “get healthcare costs under control”

World of DTC Marketing

SUMMARY: A new survey from the Kaiser Family Foundation and the Purchaser Business Group on Health shows signs that corporate executives might be warming to the idea of government getting more involved to rein in the excesses of the healthcare system.

Biden Backs Suspending Patents on Covid Vaccines

NY Times

The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.

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Pfizer forecasts $26B in coronavirus vaccine revenue this year

Bio Pharma Dive

The sum is $11 billion higher than Pfizer had estimated in February and, if realized, would make the vaccine the highest grossing pharmaceutical product by revenue in a single year

Pharma’s paid media fails

World of DTC Marketing

The Washington Post reported last year that health and pharmaceutical companies spent almost $1 billion on just Facebook mobile ads in 2019. A complete waste of money, time and effort.

Tackling diabetes & ALS with cell therapy

Pharma Phorum

Israeli company Kadimastem is developing regenerative medicine therapies based on differentiated cells derived from human embryonic stem cells to treat diseases such as Amyotrophic lateral sclerosis (ALS) and diabetes.

Pfizer/BioNTech and Moderna Seek Full FDA Approval for COVID-19 Vaccines

BioSpace

Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications

A worrisome side effect stalls a closely watched multiple myeloma drug

Bio Pharma Dive

Pfizer halted a key trial of one of the most advanced bispecific antibody drugs in development for the blood cancer after several cases of peripheral neuropathy

Pharma panics over patent wavers

World of DTC Marketing

WHAT NOW? The Biden administration’s decision to support a temporary waiver of Covid-19 vaccine patents prompted instant outrage in the pharma sector, which argues that the move rides roughshod over their intellectual property rights and will discourage US innovation while sending jobs abroad.

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Why relationships are key in rare disease patient engagement

Pharma Phorum

Real-world data is a vital part of rare disease drug development, but to get a true picture of patients’ unmet needs pharma should take a broader view of their lived experiences, says Xperiome’s Jeremy Edwards.

Mutually empowering – semantic-based machine learning and subject matter expertise

Pharma R&D Today

In a day dedicated to emerging science and technologies at the Pistoia Alliance virtual conference Collaborative R&D in Action , SciBite CTO James Malone opened the program with a compelling exploration of use cases for semantic-based machine learning (ML).

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Roivant valued at $7B in blank-check merger, bucking SPAC slowdown

Bio Pharma Dive

Vivek Ramaswamy's unusual biotech holding company will go public through a deal with Montes Archimedes Acquisition Corp. that nets Roivant $611 million

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Australian Researchers Say Best COVID-19 Vaccines 58% Effective at 250 Days

BioSpace

Next year, people are likely to need an annual COVID-19 vaccination just like they need an annual flu shot

performance-io adds Jason McKenna as a non-executive director

Pharma Phorum

UK-based performance-io has added to its senior team through two promotions and the appointment of STEM Healthcare CEO Jason McKenna as a non-executive director.

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Revealing the secret cocoa pollinators

Scienmag

International research team led by Göttingen University investigates landscape and farm-level man-agement in cocoa agroforests in Indonesia Credit: Manuel Toledo The importance of pollinators to ensure successful harvests and thus global food security is widely acknowledged.

Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

Bio Pharma Dive

The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.

After a Decade Without Executions, South Carolina’s Solution: Bring Out the Firing Squad

NY Times

State lawmakers have voted to add the firing squad as an alternative to the electric chair or lethal injection, with the drugs used for capital punishment in short supply. Capital Punishment Law and Legislation South Carolina McMaster, Henry Drugs (Pharmaceuticals

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7 Best Metformin Alternatives For Type 2 Diabetes

Druggist

Metformin is the most commonly prescribed medication for the treatment of diabetes in the UK. It is also one of the most prescribed drugs overall in the UK. As with other drugs, it is possible to experience side effects during the treament or medicine may not be suitable.

Delay of Pregnancy Among Physicians vs Nonphysicians

JAMA Internal Medicine

This cohort study compares patterns of childbirth among physicians vs nonphysicians

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ICER, unconvinced by Biogen data, suggests low price for Alzheimer's drug

Bio Pharma Dive

The influential watchdog group found the evidence supporting aducanumab "insufficient" to determine a health benefit and suggested the drug would be cost effective at up to $8,300 per year, well short of what some analysts are predicting

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Pfizer Seeks Full FDA Approval for Its Covid-19 Vaccine

NY Times

The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months. internal-essential Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) BioNTech SE Pfizer Inc

Roche’s Tecentriq gets fourth European lung cancer indication

Pharma Phorum

Roche’s cancer immunotherapy Tecentriq has been granted a new use by European regulators, for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC).

COVID-19 in the News: Heart Inflammation, Vaccine Effectiveness and More

BioSpace

There’s a fair amount of new information coming out about COVID-19 and vaccines. Here’s a roundup of some of the top stories

Sage braces for make-or-break depression data

Bio Pharma Dive

The biotech's latest earnings call focused less on revenue and more on an experimental drug for depression that's close to having important study results

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Pfizer Seeks Full F.D.A. Approval for Its Covid Vaccine

NY Times

The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months. internal-essential Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) BioNTech SE Pfizer Inc

Hidden compliance risks for life sciences companies

Pharma Phorum

The life sciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson.

Janssen seeks EU approval for first CAR-T therapy cilta-cel

Pharma Times

Cilta-cel is an investigational CAR-T cell therapy for the treatment of relapsed/refractory multiple myeloma

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CSL closes deal for UniQure gene therapy in hopeful sign for M&A

Bio Pharma Dive

Completion of the buyout eases concerns the arrangement might be held up by the FTC, which has signaled it will step up scrutiny of life sciences deals

W.H.O. Approves China’s Sinopharm Vaccine for Emergency Use

NY Times

Sinopharm is the first Chinese shot to be classified as safe and effective by the World Health Organization, allowing the vaccine to be more widely distributed to poor and middle-income nations.

Small Pharma stock market launch funds DMT-based depression drug trial

Pharma Phorum

UK-based Small Pharma has launched on the Toronto’s TSX Venture Exchange, raising 58 million Canadian dollars (around £34m) to develop medicines based on N,N-dimethyltriptylene (DMT) to treat depression.

Researchers speed identification of DNA regions that regulate gene expression

Scienmag

Jude Children’s Research Hospital scientists have developed a highly efficient method to address a major challenge in biology–identifying the genetic ‘switches’ that regulate gene expression. Credit: St. Jude Children’s Research Hospital St.

Esker, a new biotech startup, launches with plans to make targeted immune drugs

Bio Pharma Dive

Led by a former MyoKardia executive, Esker Therapeutics is developing a drug that could eventually compete with one of Bristol Myers Squibb's most closely watched candidates

Pfizer Will Seek Approval to Give Covid Vaccine to Children

NY Times

The company said it also plans to apply this month for full F.D.A. approval — not just emergency authorization — for the vaccine’s use in adults.