GSK plc

GSK

GB00BN7SWP63

Pharmaceuticals

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1,648 ^GBX	+0.75%		+4.10%	+13.67%

Apr. 24	CureVac Begins Early Stage Portion of Investigational Vaccine Trial	MT
Apr. 24	Global markets live: Heineken, AT&T Hasbro, Visa, Boeing...

GlaxoSmithKline : Hikma, Vectura in dispute with FDA over generic Advair

November 09, 2017 at 02:53 am EST

LONDON (Reuters) - Hikma (>> Hikma Pharmaceuticals) and its partner Vectura (>> Vectura Group PLC) are in dispute with the Food and Drug Administration over their plans to launch a generic copy of GlaxoSmithKline's (>> GlaxoSmithKline) popular lung drug Advair in the U.S. market, delaying any eventual approval.

Hikma said on Thursday it expected the dispute process to be completed in the first quarter of 2018, at which point it would "update the market and provide further details on timelines".

(Reporting by Ben Hirschler; editing by Tom Pfeiffer)

Stocks treated in this article : Vectura Group PLC, GlaxoSmithKline, Hikma Pharmaceuticals

Stocks mentioned in the article

	Add to a list Add to a list 0 selected To use this feature you must be a member Log in Sign up	Price	Change	5d. change	Capi.
	HIKMA PHARMACEUTICALS PLC	1,876 GBX	+3.50%	+4.58%	5B
	VECTURA GROUP	164.8 GBX	-.--%	-.--%	1.38B

Latest news about GSK plc

CureVac Begins Early Stage Portion of Investigational Vaccine Trial	Apr. 24	MT
Global markets live: Heineken, AT&T Hasbro, Visa, Boeing...	Apr. 24
GSK's Application for Jemperli's Expanded Indication Accepted by FDA for Priority Review	Apr. 24	MT
CureVac, GSK Launch Phase 1/2 Trial of Bird Flu Vaccine Candidate	Apr. 24	MT
GSK : Gets a Sell rating from JP Morgan	Apr. 24	ZD
GSK : Gets a Buy rating from Bernstein	Apr. 24	ZD
GSK plc Announces the US Food and Drug Administration Accepted the Supplemental Biologics License Application for Jemperli	Apr. 24	CI
GSK: FDA priority review for endometrial cancer	Apr. 24	CF
GSK's Jemperli with chemotherapy accepted for priority review by FDA	Apr. 24	AN
GSK Secures US FDA's Priority Review for Expanded Use of Endometrial Cancer Treatment	Apr. 24	MT
GSK Says U.S. FDA Accepts New Indication Filing For Jemperli	Apr. 24	RE
Edwards Lifesciences Corporation: The story continues	Apr. 23
European Equities Close Higher in Monday Trading; EC Probes TikTok Over Possible DSA Violations	Apr. 22	MT
GSK Reports Positive Data for Gonorrhea Treatment Gepotidacin, Shingles Vaccine Shingrix	Apr. 17	MT
GSK: positive clinical results for gonorrhea	Apr. 17	CF
Gsk plc Announces New Long-Term Data Show Shingrix Continues to Provide High Protection Against Shingles in Adults Aged 50 and over for More Than A Decade	Apr. 17	CI
GSK: shingles virus effective for over 10 years	Apr. 17	CF
GSK hails data on Shingles vaccine and gonorrhoea treatment	Apr. 17	AN
GSK's Uncomplicated Urogenital Gonorrhea Treatment Meets Primary Endpoint in Late-stage Trial	Apr. 17	MT
GSK's Shingles Vaccine Shows High Efficacy Among Older Adults in 11-Year Follow-Up Trial	Apr. 17	MT
GSK plc Announces Positive Results from the Pivotal Eagle-1 Phase III Trial for Gepotidacin	Apr. 17	CI
China GDP Beat Fails to Boost Sentiment as UK's FTSE 100 Index Sheds Nearly 2%	Apr. 16	MT
GSK Says US FDA Accepts Meningococcal Vaccine Candidate for Regulatory Review	Apr. 16	MT
GSK plc Announces US Food and Drug Administration Accepts for Review Biologics License Application for its 5-in-1 Meningococcal ABCWY Vaccine Candidate	Apr. 16	CI
GSK: vaccine accepted for FDA review	Apr. 16	CF

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Company Profile

GSK plc is a global biopharma company. The Companyâs segments include Commercial Operations and Research and Development. It develops cancer medicines for patients, including ovarian cancer, endometrial cancer, and multiple myeloma. It has developed monoclonal antibodies to help treat different diseases. Its product areas include vaccines, specialty medicines, and general medicine. It is also focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. Its vaccine portfolio includes more than 20 vaccines that help to protect people from a range of diseases and infections, including meningitis, shingles and flu, among others. Its specialty medicines include medicines for immune-mediated conditions. Its specialty medicines are also engaged in developing medicines for respiratory disease and HIV. Its general medicines include inhaled medicines for asthma and chronic obstructive pulmonary disease, antibiotics, and medicines for skin diseases.

Sector

Pharmaceuticals

Calendar

2024-04-29 - European Society of Clinical Microbiology and Infectious Diseases Meeting

Related indices

STOXX EUROPE 600 (EUR) , FTSE 100

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GSK PLC : 2023 ended on a strong note; medium- to long-term guidance raised

February 02, 2024 at 09:40 am EST

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Analysts' Consensus

Sell

Buy

Mean consensus

OUTPERFORM

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Last Close Price

16.36 GBP

Average target price

20.06 GBP

Spread / Average Target

+22.60%

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Sector Other Pharmaceuticals

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PFIZER, INC.	-8.75%	149B

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GSK plc

Equities

GSK

GB00BN7SWP63

Pharmaceuticals

GlaxoSmithKline : Hikma, Vectura in dispute with FDA over generic Advair

Stocks mentioned in the article

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