Mon.Sep 19, 2022

Back-to-back gene therapy approvals give Bluebird shot at survival

Bio Pharma Dive

The FDA's clearances of Zynteglo and Skysona are a boost to Bluebird, and could help lift the research field after a series of setbacks. But selling the high-priced therapies will be a challenge

EMA CHMP recommends authorisation of AstraZeneca’s Evusheld for Covid-19

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

Vesalius Therapeutics, a buzzy, Flagship-backed startup, cuts jobs six months after public launch

Bio Pharma Dive

When the company debuted in March, it announced plans to hire 200 employees over two years. Now, it’s laid off nearly half its staff in a year when the biotech sector has experienced a sharp market downturn

FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients.

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

Optimizing pharmaceutical innovation

Bio Pharma Dive

Elevate pharma product development and marketing through collaboration with physician experts

Pfizer Announces Positive Top-Line Results from Phase 3 Study in 20-Valent Pneumococcal Conjugate Vaccine in Infants in the European Union

The Pharma Data

More Trending

Intranasal TIPs therapy study shows potential to reduce COVID-19 transmission

Outsourcing Pharma

Gladstone Institutes seek FDA approval for human clinical trial after single-dose, intranasal TIPs treatment for SARS-CoV-2 infection limits transmission in infected animals by decreased viral shedding. Ingredients

Theravance, flush with royalty cash, buys shares from GSK

Bio Pharma Dive

The planned transaction will further unwind the respiratory disease company’s relationship with GSK, which dates back two decades

153
153

Biogen and Sage rectifiers Present New Analyses at Psych Congress farther assessing the efficacity and Safety of Zuranolone

The Pharma Data

BiogenInc.( Nasdaq BIIB) and savant rectifiers,Inc.(

A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona

Fierce Pharma

A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona. Mon, 09/19/2022 - 10:21

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

MeiraGTx unveils Ireland’s first commercial-scale gene therapy manufacturing site

BioPharma Reporter

MeiraGTx has formally opened its new GMP gene therapy manufacturing operations in Shannon, Ireland. Bio Developments

In Zantac litigation at state level, drugmakers face claims for cancer types not covered in federal action

Fierce Pharma

In Zantac litigation at state level, drugmakers face claims for cancer types not covered in federal action. kdunleavy. Mon, 09/19/2022 - 11:29

83

Polyplus extends portfolio designed to support mRNA development

BioPharma Reporter

Polyplus, a French supplier focused on advanced biologic and cell and gene therapy production, is continuing to build out its mRNA support portfolio. Upstream Processing

BioNTech's COVID vaccine sales are poised to slip, but the shot will remain a 'cash cow' in the long term: analysts

Fierce Pharma

BioNTech's COVID vaccine sales are poised to slip, but the shot will remain a 'cash cow' in the long term: analysts. fkansteiner. Mon, 09/19/2022 - 10:05

Sales 83

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Takeda Signs Virtual Power Purchase Agreement with Enel North America to Advance Renewable Energy product in the United States

The Pharma Data

RIGImmune subsumes Subintro in nasal drug delivery buyout, secures F-Prime investment

Fierce Pharma

RIGImmune subsumes Subintro in nasal drug delivery buyout, secures F-Prime investment. ntaylor. Mon, 09/19/2022 - 06:44

Your VAT payback opportunity: Further clarifications provided by the Italian tax authorities on the VAT deduction related to the pharmaceutical payback

Pharma Business Blog

With the Ruling reply no. 440/2022 dated 29th August 2022, the Italian tax authorities provided clarifications with reference to a case submitted by a taxpayer related to the the possibility of recovering the VAT included in payback amount[1], according to the Law Decree no.

Bryn advances anaphylaxis nasal spray after completing pivotal trial

Fierce Pharma

Bryn advances anaphylaxis nasal spray after completing pivotal trial. ntaylor. Mon, 09/19/2022 - 06:48

AmerisourceBergen Acquires PharmaLex for $1.28 Billion

Pharmaceutical Commerce

With deal, drug wholesaler grows its biopharma services platform.

Drugs 52

EC grants approval for BMS’ Opdualag to treat melanoma

Pharmaceutical Technology

The European Commission (EC) has granted approval for Bristol Myers Squibb ’s (BMS) fixed-dose combination, Opdualag (nivolumab and relatlimab), as first-line therapy to treat advanced (unresectable or metastatic) melanoma.

Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial 

The Pharma Data

ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis Osteoporosis accounts for 8.9

Available for Preorder: The 2022-23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

On October 11, 2022, Drug Channels Institute will release The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our thirteenth edition— remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S.

Drugs 64

AbbVie Secures Positive CHMP Opinion for Risankizumab( SKYRIZI ®) for the Treatment of Grown-ups with Moderate to Severe Crohn’s Disease

The Pharma Data

Many Vendors or One Partner? How Trust in an Insights Firm Led to Launch Success

Fierce Pharma

Many Vendors or One Partner? How Trust in an Insights Firm Led to Launch Success. mteefey. Mon, 09/19/2022 - 16:12

52

European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

The Pharma Data

Genfit builds rare liver disease pipeline with Versantis buy

Pharma Phorum

French pharma company Genfit has reached a deal to buy Versantis of Switzerland, adding three development-stage drug candidates to its portfolio of experimental liver disease therapies and continuing a strategy change first unveiled in 2020.

Exagen on why AVISE test can end the ‘diagnostic odyssey’

Outsourcing Pharma

Autoimmune diagnostics life sciences company Exagen is heralding the completion of the CAPSTONE study as evidence that its AVISE Lupus test is more clinically effective than traditional ANA methods (tANA), benefiting patients, providers and payers by enabling decisive clinical action and early treatment. Clinical Development

Heron scores FDA go-ahead for Aponvie, an IV alternative to pills for postoperative nausea

Fierce Pharma

Heron scores FDA go-ahead for Aponvie, an IV alternative to pills for postoperative nausea. kdunleavy. Mon, 09/19/2022 - 09:35

52

GSK makes Medable its preferred partner for decentralized clinical trials in 4-year deal

Outsourcing Pharma

GSK has struck a four-year contract to make Medable its preferred partner for decentralized clinical trials (DCTs), positioning the companies to work together to improve access to research. Clinical Development

bluebird bio gets green light for Skysona gene therapy in the US

BioPharma Reporter

The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bioâs Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).

Which pharmaceutical companies have the most drug patents in Czech Republic?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Czech Republic. Patents must be filed in each country (or, in some cases regional patent office) where patent protection…. The post Which pharmaceutical companies have the most drug patents in Czech Republic? appeared first on DrugPatentWatch - Make Better Decisions. Infographic

Drugs 63

Evotec breaks ground on Toulouse biologics manufacturing facility

BioPharma Reporter

Evotec SE has officially launched the construction of its J.POD biologics manufacturing facility at its Campus Curie in Toulouse, France. Upstream Processing

Teva CEO Schultz likely won't renew employment contract next year: reports

Fierce Pharma

Teva CEO Schultz likely won't renew employment contract next year: reports. zbecker. Mon, 09/19/2022 - 11:01

40