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Biogen Fires Back At Critics In Defense Of Aduhelm

Management tried to sidestep controversy around the approval of Aduhelm and said it remains confident the drug will be reimbursed.

Sales & Earnings Neurology Market Access

Arvinas, Pfizer Partner To Pursue Best-In-Class Breast Cancer Strategy

Pfizer agreed to pay up to $2.4bn to share development and commercialization costs for Arvinas’ estrogen receptor degrader, including in combination with Ibrance.

Deals Cancer Business Strategies

Roche Deals With Huge Gantenerumab Curiosity At H1 Update

Roche unveiled a strong Q2 performance driven by new medicines and continued strong growth from its diagnostics division but analysts were most keen for clues on plans for gantenerumab, now in Phase III studies for Alzheimer’s disease.

Sales & Earnings Neurology Clinical Trials

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Titans Of Pharma 2021: J&J’s Gorsky Tops Big Pharma Remuneration

INFOGRAPHIC: A snapshot of the compensation packages of CEOs and R&D leaders of the world’s biggest pharmaceutical companies, alongside median employee pay and key company performance metrics.

Leadership Strategy

Pandemic Perspectives: 20-Plus Vaccines In Development As India Tackles COVID-19 Surge

From mRNA to subunit vaccines, Indian companies have 20 COVID-19 vaccine candidates, while three have already been approved. An August nod for Biological E could not just cut down time to immunize the country's population but also allow exports to resume.

India Coronavirus COVID-19

The 2021 Worldwide Pharma And Biotech R&D Scene

INFOGRAPHIC: A snapshot of the industry in key performance indicators surrounding R&D taken in early 2021.

Companies Market Intelligence

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Latest From Commercial

Where To Start Tackling ‘Long Covid’? PureTech Pioneers Lung Drug Trial

PureTech is among the very first companies to attempt to treat long Covid and hopes its anti-fibrosis drug can aid patients’ recovery

Commercial Companies

Novartis Not Nervous About SGLT2 Threat To Entresto

The company's pharma chief Marie-France Tschudin does not expect Entresto's "unique position" in heart failure to be threatened by SGLT2 inhibitors such as Jardiance and Farxiga, saying those drugs are add-ons that will be used predominantly in diabetes patients.

Cardiovascular Strategy

Anocca To Reach Clinical-Stage With T-Cell Therapies After After Series B Injection

Sweden-based Anocca AB will use a just completed $47m Series B financing to advance its industrialized cellular biology platform and pipeline of TCR-T cellular therapies into Phase I/IIa oncology clinical trials, its CEO tells Scrip

Clinical Trials Commercial

Finance Watch: $135m In Venture Capital Will Fund Amylyx’s Late-Stage ALS Drug

Private Company Edition: Amylyx will use its new cash to run a Phase III trial and submit applications seeking EU and Canadian approvals of AMX0035, but US filing plans based on prior Phase II/III data are less clear. Also, three VC firms raised new funds targeting biopharma and other investments.

Financing Innovation

Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

Rare Diseases Approvals

J&J's COVID-19 Vaccine On Track To Generate $2.5bn This Year

The company's pharma revenues grew 17.2% in the second quarter against favorable comparisons and as the COVID-19 pandemic recovery continued.

Sales & Earnings Coronavirus COVID-19
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Latest From Policy & Regulation

Price Negotiation In Part D: Big Savings On Revlimid, Ibrance, Xtandi Projected in CAP Analysis

As Democrats in the US Congress work to move legislation empowering the Health and Human Services Department to negotiate drug prices directly with manufacturers, the Center For American Progress releases an analysis on which drugs would be targeted by House bill HR 3 and how much prices could be reduced.

Pricing Debate Legislation

With Access Restricted, Aduhelm Appears Poised For A Slow Start

Reimbursement, health policy and medical experts predicted a slow rollout ahead for Biogen's new Alzheimer's treatment at a public meeting sponsored by ICER.

Neurology Market Access

Coronavirus Update: EMA To Update Comirnaty And Spikevax Labels On Cardiac Safety

Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.

Coronavirus COVID-19 Vaccines
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Latest From Research & Development

Pipeline Watch: Phase III starts In Hemophilia, Alzheimer's

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

TB Alliance CEO On Less Toxic Treatment Regimens, Pretomanid Plans

TB Alliance CEO Mel Spigelman discusses a range of new and evolving aspects pertaining to the three-drug BPaL regimen for highly drug-resistant TB, including the ZeNix trial results and adding a licensee for pretomanid. He also notes how COVID-19 has had a “terrible impact” on efforts to tackle the TB pandemic.

Research & Development Clinical Trials

Seres Plans Deep Dive After Microbiome Drug Fails In Ulcerative Colitis Trial

The company plans an intensive review to determine the path forward for SER-287. A similar deep dive led to the successful revival of its C. difficile drug, SER-109, which it plans to submit for approval.

Clinical Trials Research and Development Strategies
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