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Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers

FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.

Biologics Regenerative Medicine Regulation

EMA Antibiotics Guide Seeks To Support Global Development

The European Medicines Agency has proposed changes to its guideline on the evaluation of new antibacterial medicines so as to align some of the data requirements with those in the US and Japan.
Europe International Infectious Diseases

Bristol-Celgene: Congressional Reps Want Assurance Merger Will Not Increase Prices

Reps. Welch and Rooney urge FTC and DOJ to condition their approval of the merger on inclusion of a pricing provision.

Pricing Debate M & A Legal Issues

UK’s NICE Under Fire For New HTA Fees

Fees for appraisals that the health technology assessment body, NICE, will introduce in April could adversely impact companies with medicines for smaller indications, despite a bigger fee reduction for some manufacturers.

Europe United Kingdom Health Technology Assessment

Scottish HTA Finally OKs Roche’s Perjeta For Metastatic Breast Cancer

The Scottish health technology assessment body, the SMC, has recommended a number of products for funding under NHS Scotland: Roche’s breast cancer drug Perjeta, Pfizer’s Xeljanz for psoriatic arthritis, and two antidiabetics, MSD’s Steglatro (ertugliflozin) and Novo Nordisk’s Ozempic (semaglutide).

 

Health Technology Assessment United Kingdom Cancer
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US FDA Performance Tracker

European Performance Tracker

Global Pharma Guidance Tracker – December 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
International Europe Australia

Global Generics & Biosimilars Awards 2018

Generics bulletin was able to celebrate the outstanding progress that both teams and individuals achieved in providing greater healthcare access through generic, biosimilar and value-added medicines. Many of these achievements have been documented in Generics bulletin. Click below and enjoy the selection of articles that reflect the wide array of industry activities.

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Policy & Regulation Explore this Topic

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Medicare IPI Model Could Import Benefit Of Biosimilar Competition, Azar Suggests

HHS secretary notes Medicare Part B International Pricing Index could ‘harness’ biosimilar price competition seen abroad for US market, where follow-ons have not been able to significantly impact pricing.

Pricing Debate Regulation Medicare

Latest From Regulation

After MPs Reject Brexit Deal, UK ABPI Wants Solution 'Quickly'

Following the government’s defeat over the Brexit withdrawal deal, the life sciences industry wants the UK parliament to find a solution quickly to avoid a “no-deal” scenario.

Brexit United Kingdom

US FDA Brings Back Furloughed Workers To Inspect High-Risk Facilities

Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

Manufacturing Quality

Sanofi's Oral Type 1 Diabetes Drug Approval May Hinge On Ketoacidosis Management

US FDA also questions composite efficacy endpoint used in one of the phase III trials as sotagliflozin reaches advisory committee in attempt to become first approved oral type 1 diabetes treatment. Sanofi says that type 1 diabetes patients already manage DKA risk because it is inherent to their condition and patients did not seem bothered by the instructions to handle DKA.
Metabolic Disorders Advisory Committees

Latest From Policy

Co-Pay Vouchers May Not Be Enough To Boost Patient Adherence To Blood Thinners

Acute MI patients who received voucher had 3.3% increase in persistence with clopidogrel or ticagrelor, but no significant reduction in major adverse cardiovascular events, ARTEMIS study finds.

Policy Cardiovascular

House Oversight Drug Pricing Hearings Will Begin With Expert, Patient Witnesses

Manufacturers will avoid direct interrogation in first round, but Oversight Committee also seeking information from sponsors on reasons behind price increases. In US Senate, Susan Collins writes to HHS Secretary Alex Azar urging the department to move ahead with rebate reform.

Pricing Debate Legislation

Louisiana ‘Netflix’ Model For Hepatitis C Drugs Caps Spending At $35m Per Year

Purchasing contract for state Medicaid and Corrections programs would last up to five years and aim to treat more than 10,000 patients in first year.

Pricing Strategies Medicaid

Clinical / R&D Explore this Topic

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Latest From Research & Development

External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.

Clinical Trials Drug Approval Standards

Opioid Sponsors Enter 2019 At A Crossroads

Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the analgesics to market. 
Research & Development Neurology

What’s The Plan? US FDA Drug Development Tool Qualification Process Requires “Cultural Change”

FDA sees negotiating formal “qualification plan” as key process improvement that should ultimately accelerate pace for construction of biomarkers and other drug development tools. But it will take some getting used to.
Clinical Trials Drug Approval Standards

Commercial Explore this Topic

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Latest From Commercial

J.P. Morgan Notebook Day 4: US Generics Steady, UroGen, REGENXBIO, Dr. Reddy's In China, And Investor Sentiment Shifts

Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: US generics see gains, researcher calls for more tech transfer, and biotech investor sentiment rises as big deals bring optimism – among other items from the last day of this year's JPM. 

Business Strategies Regenerative Medicine

House Maintains Momentum For US OTC Monograph Reform, But Senate Remains A Question Mark

With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action. The House has already cleared an OTC reform measure, as part of a pandemic preparedness bill, in the first days of the legislative session.

Consumer Legislation

J.P. Morgan Notebook Day 3: Biotech Feeling Government Shutdown, AstraZeneca, Denali, Allergan, Aptinyx, Sangamo

Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: AstraZeneca's net prices set to slide in 2019; biotechs ponder disasters from government shutdown; Denali moves into gene therapy; Sangamo clarifies partnering strategy; and Scrip talks to Allergan and Aptinyx about upcoming NMDA data releases.

Business Strategies Pricing Debate

Manufacturing Explore this Topic

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Latest From Manufacturing

US FDA Brings Back Furloughed Workers To Inspect High-Risk Facilities

Though they remain unpaid, hundreds of furloughed FDA employees will return to duty to conduct routine surveillance inspections of high-risk manufacturing facilities.

Manufacturing Quality

Public/Private Cooperation, Tailored Assistance Deemed Key To Enhancing Quality Of US Drug Imports

Public health experts tell committee that much work lies ahead in strengthening the regulatory systems of low-and middle-income countries, and recommend ways to bolster these systems and improve the quality of imports.
Quality Manufacturing

PIC/S Considers New System For Monitoring Compliance By Members

As more and more regulatory authorities line up to join the informal co-operative scheme for pharmaceutical inspectorates, PIC/S, there are plans to discuss the possible introduction of an annual reporting scheme to check ongoing compliance by existing members.
International Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

House Maintains Momentum For US OTC Monograph Reform, But Senate Remains A Question Mark

With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action. The House has already cleared an OTC reform measure, as part of a pandemic preparedness bill, in the first days of the legislative session.

Consumer Legislation

EllaOne Firm Endorses UK Reproductive Rights Group's Push For OTC Sales Of Emergency Contraceptives

EllaOne manufacturer HRA Pharma supports British Pregnancy Advisory Service's call to scrap mandatory consultations for emergency contraceptives by switching the medicines from pharmacy-only sales to OTC. BPAS says there are “no risks which outweigh its use and it is considerably safer than many medicines sold straight from the shelf in the UK."

Consumer Prescription To Otc Switch

Burt’s Bees Hopes Third Time’s A Charm In Oral Care With P&G As Provider

Clorox and Procter & Gamble embarked on a strategic licensing partnership to market Burt’s Bees toothpastes, available now in mass retail doors. Billed as simple formulas for adults and kids, with or without fluoride, the line marks the third swing at toothpaste for the iconic natural brand.

Consumer Deals
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