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Regeneron On Genetics R&D: 'It's Our Oxygen'
Regeneron is pointing to early research in genetics as the lifeline that will deliver new drugs into the clinic as...
Scrip - November 24, 2017
IPO Update: Biopharma Firms Give Thanks For Receptive US Investors
Six biopharma firms went public in the US in November during the three weeks leading up to Thanksgiving, raising $539.5m...
Scrip - November 24, 2017
NAD Head Laura Brett On Program Streamlining, Class Action Climate And Mascara Feuds
A Q&A with Laura Brett, four months into her new role as director of the National Advertising Division.
Scrip - November 24, 2017
Implied Nudity In BOCA Toothpaste Ad Objectifies Women, UK Watchdog Says
The UK’s Advertising Standards Authority ruled Nov. 22 that the image of a reclining, seemingly naked woman in an ad...
Scrip - November 24, 2017
Pfizer Persists: Big Opportunities And Challenges In Vaccines
The big pharma has two vaccines that have progressed to late-stage development, one for Clostridium difficile infection and the other...
The Pink Sheet - November 24, 2017
Pfizer Persists: Big Opportunities And Challenges In Vaccines
The big pharma has two vaccines that have progressed to late-stage development, one for Clostridium difficile infection and the other...
Scrip - November 24, 2017
Business As Usual For German Medtechs Amid Political Uncertainty, But EU Reg Cost Fears Mount
Germany has joined the unfortunate group of global economies coupled with the tag "political uncertainty." That much was assured when...
Scrip - November 24, 2017
Brexit: Vital Strategies For Keeping Devices On EU And UK Markets
As the Brexit clock ticks, fewer organizations are willing to risk waiting for the political fog to clear, preferring to...
Scrip - November 24, 2017
Pipeline Watch: Phase III Progress With Tecentriq, Viaskin Peanut And Capalizumab
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical...
Scrip - November 24, 2017
Pipeline Watch: Phase III Progress With Tecentriq, Viaskin Peanut And Capalizumab
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical...
Scrip - November 24, 2017
J&J’s Talc Winning Streak Continues With Calif. Mesothelioma Verdict
A California jury sided with J&J Nov. 16 in the first trial over whether alleged asbestos in the firm's talcum...
Scrip - November 24, 2017
Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue
Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA...
Scrip - November 24, 2017
Exec Chat: How B Braun Is Staying Ahead Of The APAC Game
B Braun Medical's Asia-Pacific operations has increasingly grown; sales from the region now makes up the third biggest chunk of...
Scrip - November 24, 2017
EMA Recommends New Approaches To Characterize Toxicity Of Anticancer Drugs
The European Medicines Agency has outlined new approaches for collecting and reporting of safety data to help better understand the...
Scrip - November 24, 2017
Global CRISPR Revolution Gathers Pace, Raising Hopes – And Concerns
CRISPR technology was invented just five years ago but is so accurate, versatile, easy to use, and inexpensive that it...
The Pink Sheet - November 24, 2017
Global CRISPR Revolution Gathers Pace, Raising Hopes – And Concerns
CRISPR technology was invented just five years ago but is so accurate, versatile, easy to use, and inexpensive that it...
Scrip - November 24, 2017
VIDEO: Abivax CEO Highlights Pipeline Assets, Including Lead HIV Drug
Abivax CEO Dr. Hartmut Ehrlich talks to Scrip senior editor Lucie Ellis about the progress and next development steps for...
Scrip - November 24, 2017
Trade Expert: New TPP Deal A Missed Opportunity For US
The 11 remaining countries linked to the TPP deal that was being negotiated by the Obama administration struck a deal...
Scrip - November 24, 2017
Trade Expert: New TPP Deal A Missed Opportunity For US
The 11 remaining countries linked to the TPP deal that was being negotiated by the Obama administration struck a deal...
Scrip - November 24, 2017
No More 'Hidden' Facilities, US FDA Tells Generic Sponsors
Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible...
Scrip - November 24, 2017
FTC Scrutiny Of Profit Seeking In Drug Supply Chain In Fact-Finding Mode
Agency hears from experts on whether PBMs and group purchasing organizations operate under misaligned incentives.
Scrip - November 24, 2017
US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting
Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.
Scrip - November 24, 2017
Adherence Issues Add Weight To Digital Trials Push
Technology advancement has brought a wave of change in healthcare, with an increasing number of key pharma players now recognizing...
Scrip - November 24, 2017
Adherence Issues Add Weight To Digital Trials Push
Technology advancement has brought a wave of change in healthcare, with an increasing number of key pharma players now recognizing...
Scrip - November 24, 2017
Alex Azar And The Return Of Republican-Style Price Negotiation
The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but...
Scrip - November 24, 2017
FDA's NDA And BLA Approvals: Juluca
Original new drugs and biologics recently approved by US FDA.
The Pink Sheet - November 24, 2017
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
The Pink Sheet - November 24, 2017
Shopping Spree Not Over For Philips, Bags Data Analytics Start-Up
Philips has made its eighth acquisition this year to date with the addition of US start-up Analytical Informatics to its...
Medtech Insight - November 24, 2017
FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers
US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for...
The Pink Sheet - November 24, 2017
Don't Sleep On DTC Compliance: FDA Dings Zolpimist Superiority Claim Vs Ambien
Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior...
The Pink Sheet - November 24, 2017
Will HTA Bodies Accept Your Innovative Trial Design?
Innovative trial designs add a new layer of uncertainty for health technology appraisal bodies. They are likely to adapt to...
The Pink Sheet - November 24, 2017
European Commission Finally Delivers On GMP Standards For ATMPs
Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission...
The Pink Sheet - November 24, 2017
QUOTED. Nov. 24, 2017
Check out what Dartmouth University's Aaron Kaplan had to say about US FDA's role in designing pivotal trials of new...
Medtech Insight - November 24, 2017

Regeneron On Genetics R&D: 'It's Our Oxygen'
Regeneron is pointing to early research in genetics as the lifeline that will deliver new drugs into the clinic as...
Scrip - November 24, 2017
IPO Update: Biopharma Firms Give Thanks For Receptive US Investors
Six biopharma firms went public in the US in November during the three weeks leading up to Thanksgiving, raising $539.5m...
Scrip - November 24, 2017
NAD Head Laura Brett On Program Streamlining, Class Action Climate And Mascara Feuds
A Q&A with Laura Brett, four months into her new role as director of the National Advertising Division.
Scrip - November 24, 2017
Implied Nudity In BOCA Toothpaste Ad Objectifies Women, UK Watchdog Says
The UK’s Advertising Standards Authority ruled Nov. 22 that the image of a reclining, seemingly naked woman in an ad...
Scrip - November 24, 2017
Pfizer Persists: Big Opportunities And Challenges In Vaccines
The big pharma has two vaccines that have progressed to late-stage development, one for Clostridium difficile infection and the other...
Scrip - November 24, 2017
Business As Usual For German Medtechs Amid Political Uncertainty, But EU Reg Cost Fears Mount
Germany has joined the unfortunate group of global economies coupled with the tag "political uncertainty." That much was assured when...
Scrip - November 24, 2017
Brexit: Vital Strategies For Keeping Devices On EU And UK Markets
As the Brexit clock ticks, fewer organizations are willing to risk waiting for the political fog to clear, preferring to...
Scrip - November 24, 2017
Pipeline Watch: Phase III Progress With Tecentriq, Viaskin Peanut And Capalizumab
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical...
Scrip - November 24, 2017
Pipeline Watch: Phase III Progress With Tecentriq, Viaskin Peanut And Capalizumab
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical...
Scrip - November 24, 2017
J&J’s Talc Winning Streak Continues With Calif. Mesothelioma Verdict
A California jury sided with J&J Nov. 16 in the first trial over whether alleged asbestos in the firm's talcum...
Scrip - November 24, 2017
Biocon, Dr Reddy’s Might Be Out Of The Woods On GMP Issue
Two Indian firms – Biocon and Dr Reddy’s – have received crucial establishment inspection reports (EIRs) from the US FDA...
Scrip - November 24, 2017
Exec Chat: How B Braun Is Staying Ahead Of The APAC Game
B Braun Medical's Asia-Pacific operations has increasingly grown; sales from the region now makes up the third biggest chunk of...
Scrip - November 24, 2017
EMA Recommends New Approaches To Characterize Toxicity Of Anticancer Drugs
The European Medicines Agency has outlined new approaches for collecting and reporting of safety data to help better understand the...
Scrip - November 24, 2017
Global CRISPR Revolution Gathers Pace, Raising Hopes – And Concerns
CRISPR technology was invented just five years ago but is so accurate, versatile, easy to use, and inexpensive that it...
Scrip - November 24, 2017
VIDEO: Abivax CEO Highlights Pipeline Assets, Including Lead HIV Drug
Abivax CEO Dr. Hartmut Ehrlich talks to Scrip senior editor Lucie Ellis about the progress and next development steps for...
Scrip - November 24, 2017
Trade Expert: New TPP Deal A Missed Opportunity For US
The 11 remaining countries linked to the TPP deal that was being negotiated by the Obama administration struck a deal...
Scrip - November 24, 2017
Trade Expert: New TPP Deal A Missed Opportunity For US
The 11 remaining countries linked to the TPP deal that was being negotiated by the Obama administration struck a deal...
Scrip - November 24, 2017
No More 'Hidden' Facilities, US FDA Tells Generic Sponsors
Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible...
Scrip - November 24, 2017
FTC Scrutiny Of Profit Seeking In Drug Supply Chain In Fact-Finding Mode
Agency hears from experts on whether PBMs and group purchasing organizations operate under misaligned incentives.
Scrip - November 24, 2017
US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting
Agency to discuss results of report, as well as pending 2018 pilot project designed to modernize its hiring practices.
Scrip - November 24, 2017
Adherence Issues Add Weight To Digital Trials Push
Technology advancement has brought a wave of change in healthcare, with an increasing number of key pharma players now recognizing...
Scrip - November 24, 2017
Adherence Issues Add Weight To Digital Trials Push
Technology advancement has brought a wave of change in healthcare, with an increasing number of key pharma players now recognizing...
Scrip - November 24, 2017
Alex Azar And The Return Of Republican-Style Price Negotiation
The nomination of a former drug industry executive to run HHS is obviously good news for the biopharma sector, but...
Scrip - November 24, 2017

Pfizer Persists: Big Opportunities And Challenges In Vaccines
The big pharma has two vaccines that have progressed to late-stage development, one for Clostridium difficile infection and the other...
The Pink Sheet - November 24, 2017
Global CRISPR Revolution Gathers Pace, Raising Hopes – And Concerns
CRISPR technology was invented just five years ago but is so accurate, versatile, easy to use, and inexpensive that it...
The Pink Sheet - November 24, 2017
FDA's NDA And BLA Approvals: Juluca
Original new drugs and biologics recently approved by US FDA.
The Pink Sheet - November 24, 2017
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
The Pink Sheet - November 24, 2017
FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers
US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for...
The Pink Sheet - November 24, 2017
Don't Sleep On DTC Compliance: FDA Dings Zolpimist Superiority Claim Vs Ambien
Warning letter objects to webpage and meeting exhibit material for excluding any risk information and suggesting mist formulation is superior...
The Pink Sheet - November 24, 2017
Will HTA Bodies Accept Your Innovative Trial Design?
Innovative trial designs add a new layer of uncertainty for health technology appraisal bodies. They are likely to adapt to...
The Pink Sheet - November 24, 2017
European Commission Finally Delivers On GMP Standards For ATMPs
Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission...
The Pink Sheet - November 24, 2017

Pfizer’s Safe House: Peter Honig Builds A Regulatory Model For The Future
In Vivo talks to Pfizer SVP for worldwide safety and regulatory Peter Honig on the challenges of establishing – and...
IN VIVO - November 21, 2017

Shopping Spree Not Over For Philips, Bags Data Analytics Start-Up
Philips has made its eighth acquisition this year to date with the addition of US start-up Analytical Informatics to its...
Medtech Insight - November 24, 2017
QUOTED. Nov. 24, 2017
Check out what Dartmouth University's Aaron Kaplan had to say about US FDA's role in designing pivotal trials of new...
Medtech Insight - November 24, 2017

Mannatech Makes Hash Of Ingredient Identities In Label, Online Claims
Mannatech crosses FDA line on promoting supplements to treat inflammation and tripped on labeling regulations in differentiating MannaBears and other...
The Rose Sheet - November 22, 2017

Step Pharma closes €14.5mm Series A round
Step Pharma (developing immune disease therapeutics) raised €14.5mm ($17mm) through a two-tranche Series A round. Participants included new investor Pontifax and returning backers Kurma Partners (lead), Bpifrance, Inserm Transfert Initiative, Idinvest, Sygnature Discovery, and the Imagine Institute.
Strategic Transactions - November 23, 2017
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